The QMN Weekly Bulletin
Medical Devices / Postmarket Safety

Devicemaker Cited for MDR Reporting Problems, Resulting in Patient Death

April 22, 2016
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Device manufacturer Moss Tubes has been cited for multiple alleged reporting violations tied to product failures, one of which apparently resulted in a patient death.

A Form 483 inspection report cited the New York-based company for six reporting and procedural violations concerning its line of gastronomy feeding tubes. Two of the company’s violations concerned its failure to promptly notify the FDA of at least two apparent device failures leading to patient complications, while the others concerned a lack of internal review and compliance mechanisms.

All of the complaints stem from an inspection conducted between Nov. 2 and Nov. 12 at the company’s headquarters.

The most serious allegations concern Moss’ failure to supply the FDA with mandatory medical device reports alerting the agency to device problems within 30 days. The inspection identified at least two such cases, the first involving a patient who received a Moss gastronomy tube as part of a surgical procedure that perforated the patient’s intestine, leading to sepsis and eventual death, the 483 states.

The second incident of the company failing to file a timely MDR report following an apparent malfunction concerned another patient whose gastronomy tube deflated following insertion, and deflated again several hours later when the surgeon opened the patient back up and reinflated the tube.

A potential third incident involved an MDR report submitted to the FDA that listed the malfunctioning product’s lot number as “unknown,” even though another company report apparently showed that it did know the product’s lot number. Because large swaths of the 483 have been redacted, it is not possible to determine whether this apparent MDR failing is related to either of the other MDR cases cited.

Along with the MDR problems, Moss also was cited for failing to formally establish procedures for receiving, reviewing and evaluating complaints. The inspector determined that some complaints the company received “were found to contain inadequate complaint investigations,” while one investigation it conducted apparently concerned two separate instances.

Another concern was that the company apparently lacks established agreements with suppliers notifying them of product changes, such as in tubing design or manufacturing. The inspector also notes that Moss does not provide its supplier with information about the types of finished products it requires versus other manufacturers.

Lastly, the 483 contends that Moss did not perform quality audits “at defined intervals and at a sufficient frequency to determine whether the quality systems activities and results comply with quality systems procedures.” More specifically, it notes that the firm has no documentation showing quality audits conducted between 2013 and 2015.

Moss Tubes CEO Michael Moss said his company responded to the agency’s allegations within 30 days.

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