The QMN Weekly Bulletin

Poor Complaint Handling Lands Insightra Medical Warning

July 24, 2015

The FDA slapped a warning letter on a California manufacturer of balloon catheters and inguinal hernia implants for not adequately evaluating complaints to determine device failure.

During a Feb. 19 to 24 inspection of Insightra Medical’s Irvine, Calif., facility, investigators determined that four of 12 complaints were not adequately investigated. In one patient death case, the firm had very limited information on the patient and event, the May 21 letter says. The company conducted an investigation with the device distributor, but the catheter involved in the death was not made available and no further conclusions could be made.

In instances where a distributor doesn’t provide information necessary for an investigation, the manufacturer should contact the end user directly, the FDA says.

When a device is not returned, companies should test reserve samples or devices manufactured around the same time, review device history records, and analyze any service records or CAPA or nonconforming data related to the device, the FDA says.

Year in and year out, at least 65% of warning letters include citations for complaint handling. In 2012, complaint management violations topped the list for device companies — a whopping 105 warning letters cited CFR 820.198. Don’t let your company become a statistic. Get FDAnews’ Complaint Handling and Medical Device Reporting - Webinar CD/Transcript and learn how to stay compliant from a noted legal expert.