Bard® Foley Tray with Bard® Hydrophilic-Coated Foley Catheter 800061Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00801741024153), received between Oct 23, 2018 and Feb 23, 2021 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Deflation Problem” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 23, 2021Inadequate Instructions for Healthcare Professional; Inadequate Instructions for Healthcare Professional

  IT WAS REPORTED THAT THE CATHETER IN THE BARD FOLEY TRAY CONTAIN NATURAL RUBBER LATEX AS PER THE BOX, BUT THE DESCRIPTION IN THE BOX WAS MENTIONED AS LATEX FREE. THE CUSTOMER SERVICE RESPONDED THAT THE PRODUCT WAS PROCESSED DIFFERENTLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement

  MAUDE report 11367291 ↗
• MalfunctionNov 14, 2018Misassembled; Misassembled; No Flow

  IT WAS REPORTED THAT THE DRAINAGE BAG TUBING DID NOT HAVE A HOLE FOR THE URINE TO DRAIN INTO THE BAG. IT APPEARED THAT IN PLACE OF A HOLE THERE WAS SOLID PLASTIC. THE CATHETER WAS PLACED FOR URINE DRAINAGE DURING A CESAREAN SECTION. IT WAS LATER REPORTED VIA EMAIL FROM THE COMPLAINANT ON (B)(6) 2018 THAT THE BLADDER WAS DISTENDED DURING THE PROCEDURE AND ALLEGEDLY CAUSED THE PROVIDER TO HAVE SOME DIFFICULTY VISUALIZING PARTS OF THE SURGICAL FIELD DURING THE PROCEDURE. THERE WAS NO ADDED TIME TO ADMISSION OR AN ADVERSE OUTCOME. THE ISSUE WAS DISCOVERED AFTER THE PROCEDURE. THE BAG WAS REMOVED FROM THE TUBE AND THE TUBE WAS ALLOWED TO DRAIN. THE BAG WAS REPLACED WITH ONE FROM ANOTHER KIT AND WORKED NORMALLY.

  Patient problems: Abdominal Distention; No Known Impact Or Consequence To Patient; Urinary Retention

  MAUDE report 8069945 ↗
• MalfunctionOct 23, 2018Material Invagination; Deflation Problem; Material Invagination

  IT WAS REPORTED THAT THE BALLOON OF THE CATHETER WOULD NOT DEFLATE. REPORTEDLY, THE SAMPLE PORT WAS CUT WHICH DID NOT RESOLVE THE ISSUE. A SURGEON WAS CALLED IN TO REMOVE THE CATHETER. THE CATHETER WAS REMOVED BY PULLING IT OUT OF THE PATIENT. THE BALLOON STILL CONTAINED FLUID AND WAS MUSHROOMED. THE PATIENT REPORTEDLY HAD AN ENLARGED PROSTATE BEFORE USE OF THE CATHETER. THERE WAS NO IMPACT TO THE PATIENT.

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

  MAUDE report 7996933 ↗
• MalfunctionOct 23, 2018Difficult to Remove; Deflation Problem; Difficult to Remove

  IT WAS REPORTED THAT THE BALLOON OF THE CATHETER WOULD NOT DEFLATE. REPORTEDLY, THE SAMPLE PORT WAS CUT WHICH DID NOT RESOLVE THE ISSUE. THE COMPLAINANT WAS UNSURE OF HOW THE CATHETER WAS ULTIMATELY REMOVED, BUT REPORTED THAT THERE WAS NO IMPACT TO THE PATIENT. THE PATIENT REPORTEDLY HAD AN ENLARGED PROSTATE BEFORE USE OF THE CATHETER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7996823 ↗