Bard® Drain Bag Foley Tray with Bardex® All-Silicone Catheter 897516Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00801741025020), received between Sep 5, 2017 and Oct 8, 2020 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 8, 2020Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT THE BALLOON OF THE FOLEY CATHETER WAS BURST. AS PER THE FOLLOWUP INFORMATION RECEIVED ON 14SEP2020, FOLEY CATHETER WAS PLACED PRIOR TO SURGERY AND URINE RETURNED. THE SURGERY PROCEEDED AND DURING THE CASE THE PHYSICIAN ASKED IF THE FOLEY CATHETER WAS DRAINING AND THE STAFF LOOKED AT THE BAG AND THERE WAS APPROXIMATELY 500 CC OF CLEAR URINE. THEY PROCEEDED AND FINISHED THE SURGERY AND AFTER THEY WERE CLOSED THEY PULLED THE DRAPE OFF AND BEGAN CLEANING UP THE PATIENT AND SAW THAT THE FOLEY CATHETER WAS LAYING ON THE FLOOR. NO PIECES WAS APPEARED TO BE MISSING. NO IMPACT TO THE PATIENT. AFTER THE SURGERY THEY PUT ANOTHER FOLEY CATHETER IN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10649289 ↗
• MalfunctionAug 14, 2020Deflation Problem; Difficult to Remove

  THE FOLEY CATHETER BALLOON WOULD NOT DEFLATE WHEN ATTEMPTING TO REMOVE IT FROM THE PATIENT. MULTIPLE ATTEMPTS WERE MADE TO DEFLATE THE BALLOON WITHOUT SUCCESS. UROLOGY WAS CONSULTED AND HAD TO ATTEMPT TO DEFLATE THE BALLOON BUT MET WITH RESISTANCE EACH TIME. FINALLY, ON 3RD ATTEMPT, THEY WERE ABLE TO RELEASE THE BALLOON. FDA SAFETY REPORT ID# (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10413155 ↗
• MalfunctionOct 24, 2019Material Invagination; Material Invagination

  IT WAS REPORTED THAT THE CATHETER WAS PULLED OUT OF THE PATIENT AND WAS NOTED HAVING A RIDGED RING AROUND THE END, WHICH MADE IT PAINFUL TO REMOVE FOR THE PATIENT. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Pain

  MAUDE report 9232757 ↗
• MalfunctionJun 12, 2019Component Missing; Component Missing; Incomplete or Missing Packaging

  IT WAS REPORTED THAT THE FOLEY CATHETER TRAY CONTAINED TWO WATER SYRINGES AND NO LUBE SYRINGES. THE TRAY SHOULD CONTAIN ONE OF EACH.

  Patient problems: No Information; No Known Impact Or Consequence To Patient

  MAUDE report 8692138 ↗
• MalfunctionNov 29, 2017Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT THERE WAS A HOLE IN THE PACKAGING OF THE TRAY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7067993 ↗
• MalfunctionSep 5, 2017Fluid/Blood Leak; Packaging Problem

  IT WAS REPORTED THAT THE IODINE PACK LEAKED INSIDE OF THE TRAY.

  Patient problems: No Patient Involvement

  MAUDE report 6841787 ↗