Medline Industries, Inc. PAIN2011Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10195327509736), received between May 7, 2024 and May 7, 2024 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Leak/Splash” (2 reports).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 7, 2024Leak/Splash; Leak/Splash

  ACCORDING TO THE CUSTOMER, "HAD THE CATHETER COME APART FROM THE CONNECTOR TWICE AND THE FILTER COME APART FROM THE CONNECTOR TWICE."

  Patient problems: Insufficient Information

  MAUDE report 19259880 ↗
• InjuryMay 7, 2024Leak/Splash; Leak/Splash

  ACCORDING TO THE CUSTOMER, "HAD THE CATHETER COME APART FROM THE CONNECTOR TWICE AND THE FILTER COME APART FROM THE CONNECTOR TWICE. ONE OF EACH WAS ON THE SAME PATIENT. THE FILTER ITSELF DOES NOT LEAK. IT IS THE CONNECTION TO THE CONNECTOR THAT IS THE PROBLEM. THE LOCKING MECHANISM LOOSENS VERY EASILY CAUSING A LEAKAGE AT THAT JUNCTION OR IT CAN COME DETACHED COMPLETELY. I ONCE HAD A LEAK THAT I DIDN'T NOTICE AND HAD DOSED DURAMORPH."

  Patient problems: Insufficient Information

  MAUDE report 19259637 ↗