CareFusion received an FDA warning letter for failing to analyze debris and particulate matter on its shunts and inside peritoneal catheters and tubing.

The company’s corrective and preventive action investigation should have identified the material and determined its source, according to the June 6 letter posted online.

The devicemaker was aware of complaints about debris and particulate matter with its Denver Ascites Shunt and Percutaneous Access Kit with Ascites Shunt since August 2011, the letter says. The Vernon Hills, Ill., facility, which operates as a specification developer and complaint file establishment, opened a CAPA on Aug. 1, 2013, and closed it on Aug. 23.

According to the warning letter, CareFusion had received 32 complaints about particulate matter or debris since August 2011. An FDA review of 10 of those complaints found that they all contained the language: “A review of complaint data identified a previous complaint with a similar failure mode. Review of the previous complaint investigation noted corrective actions including remedial training and improved CME (controlled manufacturing environment) requirements were implemented for the previous complaint.”

However, CareFusion “could not locate the ‘previous complaint’ or associated complaint investigation and corrective actions referenced in the 10 reviewed complaint investigations,” the letter says. The FDA said it would assess the company’s corrective action on this issue during a follow-up inspection.

Additional citations related to supplier screening. For example, CareFusion’s evaluations of Level I suppliers fell short of quality system requirements. The supplier self-audit questionnaire forms for two suppliers did not include answers to “pertinent quality system questions,” the letter notes.

Meanwhile, CareFusion’s supplier corrective actions don’t always demonstrate verification, the letter says. One was initiated for occlusion complaints for the Mask Air Entrainment Adult 50/CS, which is used as a flow selector with nebulizers. The devicemaker deemed it acceptable “despite the lack of documentation to verify the corrective actions,” the letter says, adding CareFusion’s response to this citation will also need to be verified during reinspection.

The company’s MDR procedure was cited for lacking instructions on obtaining and completing the FDA 3500A form, along with the address for submitting MDR reports.

The company’s Heated Ventilator & Anesthesia Breathing Circuit and Denver Ascites Shunt and Percutaneous Access Kit with Ascites (peritoneovenous) shunt were also found to be adulterated because of changes to device materials that were not followed up by new 510(k) applications. The letter tells CareFusion to stop distributing the devices.

CareFusion spokesman Toy Kirkpatrick said the company takes the letter seriously and has “invested significantly to strengthen our quality system and regulatory compliance and controls. He added that the firm has met with the FDA and received the go-ahead on plans to recommercialize the Denver shunts and transition customers from CareFusion’s heated breathing circuits to ones made by Fisher & Paykel.

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