Medline Industries, Inc. PAIN1910Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10195327323233), received between Mar 4, 2024 and Sep 24, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Failure to Seal” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2026Material Twisted/Bent

  It was reported that "About 50% of the time, the extension tube on these extension sets is bent. They are never 100% bent/crimped so that they are occluded, but the end-users are concerned that this could pose a risk."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50889018 ↗
• MalfunctionSep 21, 2026Material Deformation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50840472 ↗
• MalfunctionMar 4, 2024Leak/Splash; Failure to Seal; Leak/Splash; Failure to Seal

  IT WAS REPORTED THAT THE PLUNGER OF A LOSS-OF RESISTANCE (LOR) SYRINGE COMPONENT WAS "NOT SEALED.".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18833474 ↗