Bard® Urethral Catheterization Tray with Red Rubber Catheter 772415Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 00801741030413), received between Jul 12, 2017 and Nov 9, 2023 — classified as 2 injuries, 25 malfunctions.

The most frequently reported specific device problem is “Component Missing” (16 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 25 most recent of 27 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 9, 2023Component Missing; Component Missing

  IT WAS REPORTED THAT THE SUB FOR THEIR STRAIGHT INTERMITTENT CATHETER KIT WAS NOW JUST A CATHETER. TO REDUCE INFECTION AND MAKE IT EASIER FOR NURSING, IT WOULD BEST BE A KIT FOR A SUB PRODUCT. CUSTOMER BIN WAS NOT BEING STOCKED BECAUSE THE SUB HAS NOT BEEN FOUND. THEY NEED TO HAVE AN APPROPRIATE SUB FOUND SOON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18104509 ↗
• InjuryJul 21, 2022Material Fragmentation; Component Misassembled; Material Fragmentation; Component Misassembled

  IT WAS REPORTED THAT IN AND OUT CATH BEING DONE ON LABOR PATIENT WITH EPIDURAL TO EMPTY BLADDER. NURSING STAFF STATED THAT THE INTERMITTENT CATHETER WAS INTACT WHEN INSERTED INTO URETHRA BUT CAME OUT MISSING THE TOP PORTION. IT WAS STATED THAT THE PATIENT ENDED UP HAVING TO UNDER CYSTOSTOMY AFTER DELIVERY. AS PER INVESTIGATOR NOTIFICATION ON 06JUL2022, IT WAS STATED THAT AN ADDITIONAL RED RUBBER CATHETER WAS RETURNED FOR SAMPLE EVALUATION.

  Patient problems: Foreign Body In Patient

  MAUDE report 15079770 ↗
• InjuryApr 6, 2022Material Fragmentation; Component Misassembled; Material Fragmentation; Component Misassembled

  IT WAS REPORTED THAT IN AND OUT CATH BEING DONE ON LABOR PATIENT WITH EPIDURAL TO EMPTY BLADDER. NURSING STAFF STATED THAT THE INTERMITTENT CATHETER WAS INTACT WHEN INSERTED INTO URETHRA BUT CAME OUT MISSING THE TOP PORTION. STATED THAT THE PATIENT ENDED UP HAVING TO UNDER CYSTOSTOMY AFTER DELIVERY.

  Patient problems: Foreign Body In Patient

  MAUDE report 14021789 ↗
• MalfunctionAug 11, 2021Partial Blockage; Partial Blockage

  IT WAS REPORTED THAT THE RED RUBBER FOLEY IN THE STRAIGHT CATHETER KIT WAS BLOCKED AND DOES NOT DRAIN. AFTER THE CATHETER FAILED, THE CUSTOMER TRIED TO FLUSH WATER BUT NOT ABLE TO FLUSH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12309634 ↗
• MalfunctionJun 30, 2021Component Missing; Component Missing

  IT WAS REPORTED THAT THE LUBRICATION PACKET WAS MISSING FROM URETHRAL TRAY FOR LOT NUMBER NGFQ4266. IT WAS FURTHER REPORTED THAT THE COLLECTION CONTAINER WAS MISSING FROM ANOTHER URETHRAL TRAY FOR LOT NUMBER NGFP0800.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12097354 ↗
• MalfunctionJun 30, 2021Component Missing; Component Missing

  IT WAS REPORTED THAT THE LUBRICATION PACKET WAS MISSING FROM URETHRAL TRAY FOR LOT NUMBER NGFQ4266. IT WAS FURTHER REPORTED THAT THE COLLECTION CONTAINER WAS MISSING FROM ANOTHER URETHRAL TRAY FOR LOT NUMBER NGFP0800.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12094603 ↗
• MalfunctionDec 5, 2020Inaccurate Flow Rate; Inaccurate Flow Rate

  IT WAS REPORTED THAT DESPITE CORRECT ANATOMICAL LOCATION PLACEMENT THE STRAIGHT CATHETER DID NOT DRAIN THE URINE. A SECOND STRAIGHT CATHETER WAS PLACED IN THE SAME LOCATION AND THE URINE WAS RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10950723 ↗
• MalfunctionOct 29, 2020Component Missing

  2 STRAIGHT CATH KITS STATED THEY HAD (2) NON LATEX, STERILE GLOVES IN THE PACKAGE AND DID NOT HAVE THE GLOVES IN THE PACKAGE.

  Patient problems: Insufficient Information

  MAUDE report 10754629 ↗
• MalfunctionOct 20, 2020Inadequate Instructions for Healthcare Professional; Inadequate Instructions for Healthcare Professional

  IT WAS REPORTED THAT THE BARD URETHRAL CATHETERIZATION TRAY WITH RED RUBBER CATHETER WAS HAVING LABELING ISSUES AND MIXED PRODUCT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10705640 ↗
• MalfunctionMar 4, 2020Component Missing

  IT WAS REPORTED THAT THE CATHETER TRAY WAS MISSING THE POVIDONE-IODINE SWABSTICKS.

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

  MAUDE report 9787964 ↗
• MalfunctionDec 13, 2019Component Missing

  IT WAS REPORTED THAT THERE WAS NO IODINE IN THE PACKET.

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

  MAUDE report 9468769 ↗
• MalfunctionOct 17, 2019Inaccurate Flow Rate; Obstruction of Flow; Inaccurate Flow Rate

  IT WAS REPORTED THAT ONCE THE FOLEY CATHETER WAS INSERTED, THE URINE WOULD NOT DRAIN. THE COMPLAINANT REPORTED THAT THE CATHETER HAD TO BE MANIPULATED IN ORDER FOR IT TO DRAIN.

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

  MAUDE report 9204662 ↗
• MalfunctionJun 20, 2019Component Missing

  IT WAS REPORTED THAT THERE WERE THREE TRAYS THAT WERE MISSING POVIDONE IODINE SWAB STICKS. NO MEDICAL INTERVENTION WAS REPORTED.

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

  MAUDE report 8718846 ↗
• MalfunctionMay 20, 2019Restricted Flow rate; Restricted Flow rate; No Flow

  IT WAS REPORTED THAT THE CATHETER HAD NO DRAINAGE FLOW. NO MEDICAL INTERVENTION WAS REQUIRED.

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

  MAUDE report 8624757 ↗
• MalfunctionMay 2, 2019Component Missing

  IT WAS REPORTED THAT THE REB RUBBER CATHETER WAS MISSING FROM THE TRAY AS THE TEAM PREPARED FOR A PROCEDURE. NO MEDICAL INTERVENTION WAS REPORTED.

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

  MAUDE report 8575491 ↗
• MalfunctionFeb 5, 2019Component Missing

  IT WAS REPORTED THAT THE BETADINE SWABS WERE MISSING FROM THE KIT. NO MEDICAL INTERVENTION WAS REQUIRED.

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

  MAUDE report 8308463 ↗
• MalfunctionDec 26, 2018Component Missing

  IT WAS REPORTED THAT THE CATHETER WAS MISSING FROM THE TRAY.

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

  MAUDE report 8196997 ↗
• MalfunctionNov 14, 2018Device Damaged Prior to Use; Difficult to Remove; Improper or Incorrect Procedure or Method; Device Damaged Prior to Use

  IT WAS REPORTED THAT THERE WAS EXTRA PLASTIC AROUND THE CATHETER; THEREFORE IT CAUSED SOME RESISTANCE AND THE CATHETER WAS FORCIBLY REMOVED. NO MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 8071967 ↗
• MalfunctionNov 13, 2018Component Missing

  IT WAS REPORTED THAT THE LUBRICANT WAS MISSING FROM THE FOLEY TRAY.

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

  MAUDE report 8065007 ↗
• MalfunctionOct 1, 2018Component Missing

  IT WAS REPORTED THAT THE CATHETER WAS MISSING FROM THE TRAY.

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

  MAUDE report 7923224 ↗
• MalfunctionSep 24, 2018Component Missing

  IT WAS REPORTED THAT THE CATHETER WAS MISSING FROM THE TRAY.

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

  MAUDE report 7903617 ↗
• MalfunctionSep 19, 2018Component Missing

  IT WAS REPORTED THAT IODINE WAS MISSING FROM FIVE CASES OF THE URETHRAL CATHETER TRAYS.

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

  MAUDE report 7889000 ↗
• MalfunctionSep 6, 2018Nonstandard Device; Appropriate Device Problem Term/Code Not Available; Nonstandard Device

  IT WAS REPORTED THAT THE CATHETER WAS TOO FLIMSY WHICH CAUSED THE HEAD OF THE CATHETER TO BE TOO LOW TO DRAIN ANY URINE WHEN THE NURSE CATHED THE PATIENT AGAIN AN HOUR LATER SHE GOT 1000ML OF URINE.

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

  MAUDE report 7852517 ↗
• MalfunctionSep 6, 2018Restricted Flow rate; Inaccurate Flow Rate; Inaccurate Flow Rate

  IT WAS REPORTED THAT WHEN THE CATHETER WAS INSERTED NOT MUCH/NO URINE DRAINED AND THE PATIENT LATER HAD A VERY LARGE RESERVE OF URINE.

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

  MAUDE report 7852512 ↗
• MalfunctionSep 4, 2018Component Missing

  IT WAS REPORTED THAT THE RED RUBBER CATHETER WAS MISSING FROM THE KIT.

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

  MAUDE report 7843979 ↗