MEDLINE DYNC1674Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 10080196840922), received between Sep 24, 2018 and Sep 25, 2026 — classified as 3 injuries, 19 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (11 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2026No Flow

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50904111 ↗
• MalfunctionSep 25, 2026Crack; Material Split, Cut or Torn

  It was reported that "PER THE NURSE, THE BAG DOES NOT LAST A MONTH AND THEIR PATIENT IS HAVING TO CHANGE THE BAGS EVERY WEEK DUE TO CRACKING/RIPPING IN THE BAG. NURSE ADVISED THE BAG TEARS SPECIFICALLY WHERE THE BAG DRAINS."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50899115 ↗
• MalfunctionSep 22, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50859673 ↗
• MalfunctionSep 21, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50841111 ↗
• MalfunctionSep 19, 2026Crack; Material Puncture/Hole; Material Split, Cut or Torn

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50832085 ↗
• MalfunctionSep 18, 2026Fluid/Blood Leak; Material Puncture/Hole

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50830884 ↗
• MalfunctionSep 16, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50791590 ↗
• MalfunctionSep 14, 2026Fluid/Blood Leak

  It was reported that the drain bag is leaking on bottom where the valve is.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50756225 ↗
• MalfunctionSep 13, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50747650 ↗
• MalfunctionSep 12, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50746586 ↗
• MalfunctionSep 9, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50697341 ↗
• MalfunctionSep 9, 2026Fluid/Blood Leak

  It was reported that "keeps leaking at the bottom seams."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50691959 ↗
• MalfunctionSep 2, 2026Fluid/Blood Leak; Material Split, Cut or Torn

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50568253 ↗
• MalfunctionAug 16, 2026Fluid/Blood Leak

  It was reported that the bags were leaking at the corner.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50266700 ↗
• MalfunctionMay 7, 2026Leak/Splash

  PER CUSTOMER, LEAKING, LIGHT STREAM OF URINE THAT WILL COME OUT.

  Patient problems: Insufficient Information

  MAUDE report 25118732 ↗
• MalfunctionApr 29, 2026Break

  (B)(6) CALLED IN STATING THAT THE PT USED THE BAGS LESS THAN 24 HOURS AND BOTH BAGS BEGAN LEAKING. THE PT THREW OUT THE BAGS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25037466 ↗
• MalfunctionApr 27, 2026Leak/Splash

  CUSTOMER REPORTED, "OUR NURSES ARE REPORTING THESE URINARY DRAINAGE BAGS LEAK REGULARLY FROM THE BOTTOM SEAL, EVEN WHEN THEY ARE NOT FULL. THEY DO NOT LAST LONG AND WE ARE HAVING TO BUY A LOT MORE OF THIS PRODUCT TO COMPENSATE FOR THE LEAKAGE."

  Patient problems: Insufficient Information

  MAUDE report 25008369 ↗
• MalfunctionFeb 27, 2026Obstruction of Flow

  ACCORDING TO THE FACILITY, THE FOLEY IS NOT DRAINING WELL WHICH CAUSES INCREASED SEDIMENT AND INCREASED CATHETER BLOCKING.

  Patient problems: Insufficient Information

  MAUDE report 24476367 ↗
• InjuryMay 21, 2024Leak/Splash; Leak/Splash

  ACCORDING TO THE CUSTOMER ON (B)(6), "THE FOLEY WAS REPLACED. URINARY DRAINAGE BAGS HAVE NOT BEEN DRAINING PROPERLY CAUSING BLADDER SPASMS AND LEAKING FROM THE SP SITE AND FROM THE PENIS ITSELF. HE HAS REQUIRED FREQUENT SUPRAPUBIC CATHETER CHANGES AS THE URINE DOES NOT DRAIN PROPERLY INTO THE DRAINAGE BAG.".

  Patient problems: Cramp(s) /Muscle Spasm(s); Pain

  MAUDE report 19360355 ↗
• InjuryMay 21, 2024Leak/Splash; Leak/Splash

  ACCORDING TO THE CUSTOMER ON 3/21, "THE FOLEY WAS REPLACED. URINARY DRAINAGE BAGS HAVE NOT BEEN DRAINING PROPERLY CAUSING BLADDER SPASMS AND LEAKING FROM THE SP SITE AND FROM THE PENIS ITSELF. HE HAS REQUIRED FREQUENT SUPRAPUBIC CATHETER CHANGES AS THE URINE DOES NOT DRAIN PROPERLY INTO THE DRAINAGE BAG.".

  Patient problems: Cramp(s) /Muscle Spasm(s); Pain

  MAUDE report 19360001 ↗
• InjuryMay 16, 2024Leak/Splash; Leak/Splash

  ACCORDING TO THE CUSTOMER ON 3/18, "THE FOLEY WAS REPLACED. URINARY DRAINAGE BAGS HAVE NOT BEEN DRAINING PROPERLY CAUSING BLADDER SPASMS AND LEAKING FROM THE SP SITE AND FROM THE PENIS ITSELF. HE HAS REQUIRED FREQUENT SUPRAPUBIC CATHETER CHANGES AS THE URINE DOES NOT DRAIN PROPERLY INTO THE DRAINAGE BAG."

  Patient problems: Cramp(s) /Muscle Spasm(s); Pain

  MAUDE report 19335009 ↗
• MalfunctionSep 24, 2018No Flow

  IT WAS REPORTED THAT THE PATIENT'S URINE WOULD NOT DRAIN INTO THE URINARY DRAINAGE BAG RESULTING IN THE PATIENT DEVELOPING BLADDER DISTENTION AND URINARY TRACT INFECTION.

  Patient problems: Urinary Tract Infection

  MAUDE report 7901600 ↗