Medline DYND160814Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10884389287408), received between Feb 25, 2019 and Sep 8, 2026 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 8, 2026Fluid/Blood Leak; Detachment of Device or Device Component

  It was reported that, "At point where the drain bag connects to the foley cath line there is a luer lock sampling port. This has been coming off and/or leaking urine.".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50668977 ↗
• InjuryJul 26, 2023Fluid/Blood Leak; Fluid/Blood Leak

  ACCORDING TO THE FACILITY ON 07/07/2023 THE FOLEY CATHETER BALLOON WAS NOTED TO BE LEAKING.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 17396451 ↗
• MalfunctionFeb 25, 2019Crack

  IT WAS REPORTED THAT A URINE METER CRACK WAS IDENTIFIED AND THAT THE PATIENT'S URINARY CATHETER WAS REPLACED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8365920 ↗