Bard® Urine Meter Foley Tray With Lubri-Sil® All-Silicone Foley Catheter 942216Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00801741024979), received between Aug 4, 2017 and Oct 8, 2024 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Material Puncture/Hole” (2 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Jun 25, 2026Open, Classified

   Due to complaints received indicating presence of contamination on the surface of pericare wipes provided with various Foley and Intermittent Catheter Trays.

   Z-3115-2026 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 8, 2024

  A NURSE INFLATED THE FOLEY BALLOON TO TEST IT BEFORE INSERTING INTO THE PATIENT AND THE BALLOON DID NOT INFLATE. THERE WAS A HOLE IN THE BALLOON AND STERILE WATER SQUIRTED OUT OF IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20396111 ↗
• MalfunctionAug 29, 2022Fluid/Blood Leak; Device Fell

  PATIENT HAD FOLEY CATHETER PLACED IN THE ED. THE CATHETER FELL OUT AND HAD TO BE REPLACED BY THE RN. THE RN TESTED THE BALLOON OF THE CATHETER THAT HAD "FALLEN OUT" AND OBSERVED THAT THE INJECTED FLUID IMMEDIATELY LEAKED OUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15310086 ↗
• MalfunctionJun 22, 2022Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE SECOND FOLEY CATHETER THAT WAS PLACED HAD FAILED. IT WAS STATED THAT A PATIENT CAME BACK INTO THE EMERGENCY DEPARTMENT SAYING THE FOLEY THAT HAD BEEN PLACED JUST FELL OUT. IT WAS A 16FR FOLEY CATHETER WHICH WAS FOUND TO HAVE A PIN HOLE ON THE BALLOON UPON INSPECTION. THEN, CUSTOMER HAD PLACED A NEW 16FR FOLEY CATHETER AND SENT THE PATIENT HOME. THE PATIENT CAME BACK AN HOUR LATER SAYING IT FELL OUT AGAIN AND THAT ONE HAD A BIG VERTICAL TEAR IN THE BALLOON AND WOULD NOT INFLATE AT ALL. THEN, CUSTOMER PLACED A 18FR FOLEY CATHETER AND SENT THE PATIENT HOME AGAIN. PER FOLLOW UP VIA EMAIL ON 14-JUN-2022, STATED THAT THE PATIENT RETURNED TO THE EMERGENCY DEPARTMENT AN HOUR AFTER THE 16FR FOLEY CATHETER WAS PLACED AND IT ALSO FELL OUT. THE REGISTERED NURSE NOTED THE BALLOON WAS DEFLATED WITH A LARGE OPEN HOLE IN IT AND THAT POINT AN 18FR CATHETER WAS PLACED AND THE PATIENT WAS SENT HOME AND THERE WERE NO FURTHER COMPLICATIONS THAT THEY WERE AWARE OF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14775000 ↗
• MalfunctionJun 1, 2022Material Puncture/Hole; Detachment of Device or Device Component; Material Split, Cut or Torn

  THIS REPORT IS FOR THE SECOND FOLEY CATHETER THAT WAS PLACED AND FAILED. A PATIENT COME BACK INTO THE EMERGENCY DEPT SAYING HIS FOLEY THAT HAD BEEN PLACED JUST FELL OUT. IT WAS A 16 FR UROMETER STYLE FOLEY AND IT HAD A PIN HOLE IN THE BALLOON ON INSPECTION. THEN WE PLACED A NEW 16 FR FOLEY AND SENT HIM HOME. HE CAME BACK AN HOUR LATER SAYING IT FELL OUT AGAIN, THIS ONE HAD A BIG VERTICAL TEAR IN THE BALLOON AND WOULD NOT INFLATE AT ALL. I SAVED THE PACKAGING BECAUSE IT WAS STILL IN THE TRASH. THEN WE PLACED AN 18 FR FOLEY AND SENT HIM HOME AGAIN. I SAVED THE PACKAGING TOO JUST IN CASE IT HAPPENS AGAIN.

  Patient problems: Insufficient Information

  MAUDE report 14564138 ↗
• MalfunctionAug 4, 2017Break

  IT WAS REPORTED THAT THE TIP OF THE WATER SYRINGE BROKE OFF IN THE INFLATION PORT, PRIOR TO INFLATION OF THE CATHETER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6766736 ↗