Five device manufacturers drew 483s for problems with complaint handling, medical device reporting, CAPAs and other nonconformances.
Philips Medical Systems: The FDA cited Philips Medical Systems for failure to investigate or properly review thousands of complaints in a Form 483 issued after a July/August 2017 inspection of the firm’s Cleveland facility.
Investigators found that out of 133,845 complaints from July 2016 to July 2017, more than 129,000 were closed based only on the assigned hazard/harm symptom code without further investigation. Nearly 1,800 complaints were not properly escalated and forwarded to the complaint-handling unit.
The Form 483 further faulted the company for its CAPA and complaint-handling procedures. The facility’s procedures for entering complaints do not describe how and when failure codes are entered, nor does the company have any procedure defining the codes. The firm only evaluated complaints and non-conformances for potential CAPAs when they meet an escalation threshold, which is not adequately defined or consistent.
The inspection also found that of 36 complaint records and associated MDR files, 21 of 36 complaint files did not list all possible associated hazards.
In addition, the firm’s procedures did not ensure control of suppliers and procedures for acceptance of incoming product were not properly established. The company’s process for handling duplicate anomaly reports was also inadequate. Lastly, the company’s written MDR procedure lacked an internal system providing for a standard review process to determine whether an event meets the reporting criteria.
Nevro Corporation: Failure to submit medical device reports, inadequate risk analysis and CAPA procedures that failed to detect recurring quality issues were just a few of the nonconformances cited on a Form 483 handed to implantable devicemaker Nevro following an October 2017 inspection of the firm’s Redwood City, California plant.
During the inspection, the firm’s chief medical officer told the FDA inspector that the company “only reports medical device reports for complaint cases where [implantable pulse generator] pocket infections require IV antibiotics and/or hospitalization.” The inspector noted that many complaints documented Nevro’s implantable products being removed due to infection complaints, and many of these were not reported.
When the inspector asked for a list of complaints that were not reported as medical device reports for which the firm’s product was explanted due to infections, he received a list of 129 complaint case files.
The inspector reviewed 123 complaints related to reports of infections and/or deaths for which the company had not yet opened corrective or preventive action files.
While reviewing the failure mode and effects analysis (FMEA) documentation, the inspector observed that levels of harm were inappropriately rated. In one case, a patient was hospitalized and diagnosed with sepsis and the Nevro IPG tested positive for staph infection. The firm’s FMEA documentation did not list the injury as life threatening even though the patient suffered multiple organ shutdowns. The FMEA also indicated that a new CAPA did not need to be initiated for the event.
Similar incidents were cited by the FDA inspector. He noted that of the 123 complaints reviewed, roughly 75 percent received only a cursory note documenting the lot history records associated with the complaint.
Other nonconformances included validation failures for the firm’s sterilization processes.
Arrowhead Dental: Class II device manufacturer Arrowhead Dental was cited for failure to develop design control and medical device reporting procedures among other quality failures in a Form 483 issued following a December 2017 inspection of the firm’s Sandy, Utah facility.
The firm lacked design control procedures for sleep apnea devices it had been selling since April 2012, the 12-item 483 said. It also did not have a design history file for its Elastic Mandibular Advancement device, and it failed to address planning, inputs, design reviews, risk, or design verifications for design changes.
The inspector observed that Arrowhead didn’t develop written MDR procedures and it lacked approved procedures for handling and evaluating complaints for the Class II devices.
Also missing were CAPA procedures and procedures to ensure that equipment is routinely calibrated, inspected checked and maintained. The firm also lacked acceptance procedures for raw materials as well as procedures to control products that don’t conform to specifications.
In addition, Arrowhead had no device master record for documentation associated with specifications and manufacturing requirements. The facility also lacked written procedures for device history records, management reviews, quality audits or training.
A Cute Baby: Class II breast pump manufacturer A Cute Baby failed to establish written medical device reporting procedures as well as procedures for evaluating complaints, according to a Form 483 the firm received following a Dec. 7, 2017 inspection of the firm’s Orem, Utah facility.
The FDA inspector said that the firm didn’t have any approved procedures in place for handling adverse events or for evaluating complaints.
The 483 also highlighted deficiencies in training and identifying training needs.
The firm lacked procedures for training employees in MDRs, complaint handling, and servicing for the devices. In addition, employees do not have documented training records for these activities.
Smith & Nephew: Smith & Nephew drew a Form 483 for multiple issues at its Memphis, Tennessee facility, including a faulty procedure for the control of nonconforming product and inadequate corrective and preventive action procedures.
The firm lacked an adequate procedure for the control of nonconforming product or to ensure that assessments of nonconforming products were properly documented. For example, the procedure required an investigation of discrepancies, including missing laser engraved batch numbers, but provided no method to ensure investigations were performed or recorded.
The FDA investigators observed that a corrective and preventive action was also not adequately established. The firm failed to conduct or record activities in a timely and effective manner. For example, a request to initiate a CAPA took over a year to be evaluated by the review board and was not signed as approved until three months after its evaluation. No investigation was performed into the cause of the problem or any subsequent impact on product.
In addition, the firm lacked an adequate complaint handling unit. Specifically, its orthopedic instrument repair processing specification procedure required information to be shared when a device could not be repaired or a deficiency became evident, but multiple device repair orders were not shared.
Read the Philips Medical Form 483 here: www.fdanews.com/03-09-18-Phillips483.pdf.
Read the Nevro Form 483 here: www.fdanews.com/03-06-18-nevrocorp483.pdf.
Read the Arrowhead Dental Form 483 here: www.fdanews.com/03-07-18-arrowheaddentalinc483.pdf.
Read the A Cute Baby Form 483 here: www.fdanews.com/03-07-18-acutebabyinc483.pdf.
Read the Smith & Nephew Form 483 here: www.fdanews.com/03-08-18-smithnephewinc483.pdf.
Medical Device Reporting Requirements
MDR requirements are an outgrowth of complaint management regulations. The FDA’s regulations in 21 CFR Part 803 – Medical Device Reporting require that companies evaluate all device complaints to determine if they involve an adverse event that must be reported to the agency.
Malfunctions must be reported when the chance of death or serious injury resulting from recurrent malfunctions is not remote. Malfunctions also need to be reported when the consequences of the malfunction affect the device in a catastrophic manner that might lead to a death or serious injury.
Manufacturers often have the most trouble determining when the likelihood of a future malfunction resulting in death or serious injury is not remote. One of the factors the FDA looks at is whether or not that particular type of malfunction has caused a death or serious injury in the past two years. If it has, the agency concludes that the risk is not remote and the event must be reported.
In addition, manufacturers must report malfunctions when:
Excerpted from the FDAnews management report: Complaint Management for Devicemakers: From Receiving and Investigating to Analyzing Trends.