PU Feeding Tube PFTM8.0P-EORecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00350770002354), received between Apr 6, 2023 and Apr 6, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Difficult to Open or Close” (1 report).

1 other recall cover devices cleared under the same FDA submission (K082238); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 6, 2023Loose or Intermittent Connection; Difficult to Open or Close

  PATIENT HAS AN 8FR AVANOS NEOMED FEEDING TUBE. THE CAP TO CLOSE OFF THE TUBE WHEN NOT IN USE IS UNABLE TO CLOSE FULLY. WHEN THE CAP IS ACTIVATED, IT POPS BACK OPEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16688827 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K082238. One submission often covers many models, so check the product and lot details in each record.

• Z-0093-2019 · Jun 4, 2018 · Terminated
  NeoMed Enteral Feeding Tubes with Enteral Only Connectors, French sizes 4.0Fr, 5.0Fr, 6.5Fr, 8.0Fr, and lengths 40cm, 60cm, 90cm. The product consists of a polyurethane feeding tu