Bard Urethral Catheterization Tray with Plastic CatheterRecalls & reported problems across all models

We found 3 models of Bard Urethral Catheterization Tray with Plastic Catheter by C. R. Bard, Inc. in the FDA's device registry (GUDID). Together they are named in 24 adverse event reports in the FDA's MAUDE database, received between May 25, 2017 and Jul 21, 2022 — classified as 24 malfunctions.

The most frequently reported specific device problem is “Component Missing” (8 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Bard Urethral Catheterization Tray with Plastic Catheter problems

Bard Urethral Catheterization Tray with Plastic Catheter models

3 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Bard® Urethral Catheterization Tray with Plastic Catheter 772514

  CATHETER, UROLOGICAL
  18 reports
• Bard® Urethral Catheterization Tray with Plastic Catheter 772416

  CATHETER, UROLOGICAL
  4 reports
• Bard® Urethral Catheterization Tray with Plastic Catheter 771114

  CATHETER, UROLOGICAL
  2 reports

Recent Bard Urethral Catheterization Tray with Plastic Catheter adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionJul 21, 2022Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT THE CATHETER IN THE URETHRAL CATHETERIZATION TRAY WAS SEALED SHUT ON THE END AND THEY HAD TO WASTE THAT PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15073721 ↗
• MalfunctionFeb 18, 2022Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE PLASTIC CATHETERS CAUSED INJURY TO THE PATIENT. NO MEDICAL INTERVENTION WAS REPORTED. PER FOLLOW UP ON 01FEB2022, NURSE STATED THAT THE PATIENT EXPERIENCED BLEEDING AND ABRASIONS TO THE URINARY TRACT AS THE CATHETER WAS NOT BEING ABLE TO INSERT CORRECTLY DUE TO BEING MET WITH RESISTANCE. STATED THAT THE PATIENT WAS MONITORED AND GIVEN PAIN MEDS AS NEEDED BUT NO OTHER MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Abrasion; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 13561977 ↗
• MalfunctionMay 27, 2021Inaccurate Flow Rate; Inaccurate Flow Rate

  IT WAS REPORTED THAT THE CATHETER WAS AIR LOCKED OR VAPOR LOCKED AS IT WOULD NOT DRAIN URINE. ALL THE ONES THAT WERE TRIED ARE FROM LOT # NGEY2221 WHEN THEY TRIED ONE FROM ANOTHER LOT NUMBER IT SEEMED TO WORK FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11894652 ↗
• MalfunctionFeb 16, 2021Component Missing; Component Missing

  IT WAS REPORTED THAT THE YELLOW LABEL ON SOME DEVICES STATED THAT THERE WAS NO STERILE GLOVES IN KIT, WHICH WAS NOT READILY APPARENT TO THE HEALTH CARE PROFESSIONAL DURING USE. THIS CAUSED THE PATIENT TO BE RE-POSITIONED AND LEFT TO FIND GLOVES AND THEN START THE PROCESS OVER, HENCE THE PROCEDURE WAS DELAYED. THE PATIENT HAD RESTRICTED SUPINE POSITION DUE TO SPINAL SACRECTOMY AND PRESENCE OF JACKSON-PRATT DRAINS ON BACK. POSITIONING AND REPOSITIONING HAPPENED MULTIPLE TIMES DUE TO MISSING GLOVES IN KIT. ALSO REPORTEDLY, THE KIT WAS MISSING LUBRICATION FOR CATHETER AND SO AN ADDITIONAL KIT HAD TO BE OPENED TO FIND LUBRICATION.

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

  MAUDE report 11333260 ↗
• MalfunctionOct 27, 2020Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT THE FOLEY CATHETERS HAD CHANGED LENGTH FROM 16. PER TROUBLESHOOTING, THE MSS NOTICED THAT THERE WERE NO DESIGN CHANGED FEMALE AND PEDIATRIC LENGTHS ARE CLEARLY MARKED ON THE PACKAGING AS PER THE FOLLOW UP VIA EMAIL ON 01OCT2020 ,THE ANOTHER PRODUCT CATALOG NUMBER RECEIVED WITH SAME ISSUE.

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

  MAUDE report 10741670 ↗
• MalfunctionOct 13, 2020Component Missing; Component Missing

  IT WAS REPORTED THAT THE YELLOW STICKER ON THE URETHRAL CATHETERIZATION KIT STATES THAT THERE WERE NO STERILE GLOVES IN THE PACKAGE. THERE WAS NO MENTION OF THE LUBRICANT, AND CERTAINLY THE ISSUE OF THE CATHETER DETACHED FROM THE BAG SO EASILY WAS CONCERNING.

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

  MAUDE report 10671433 ↗
• MalfunctionJun 10, 2020Component Missing

  IT WAS REPORTED THAT THE IODINE SWABS IN THE URETHRAL CATHETERIZATION TRAYS WERE MISSING.

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

  MAUDE report 10137135 ↗
• MalfunctionJul 19, 2019Component Missing; Component Missing

  IT WAS REPORTED THAT THE IODINE SWABSTICKS AND LATEX GLOVES WERE MISSING FROM THE TRAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8808612 ↗
• MalfunctionMar 18, 2019Break; Device Damaged Prior to Use; Device Damaged Prior to Use

  IT WAS REPORTED THAT THE TIP OF THE CATHETER INSIDE OF THE URETHRAL CATHETER TRAY WAS DAMAGED.

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

  MAUDE report 8428490 ↗
• MalfunctionDec 6, 2018Component Missing

  IT WAS REPORTED THAT THE TRAY DID NOT INCLUDE THE POVIDONE IODINE POUCH; HOWEVER, THE ORANGE LABEL ON THE OUTSIDE OF THE TRAY NOTED THAT THE POVIDONE IODINE POUCH WAS INCLUDED IN THE TRAY. NO MEDICAL INTERVENTION WAS REPORTED.

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

  MAUDE report 8137306 ↗
• MalfunctionNov 16, 2018Break; Break; Material Puncture/Hole

  IT WAS REPORTED THAT A SMALL PINHOLE WAS FOUND IN THE CATHETER DURING PLACEMENT. THE HOLE WAS LOCATED UNDER THE ORANGE COLLAR LOCATED AT THE TOP OF THE CATHETER.

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

  MAUDE report 8081975 ↗
• MalfunctionNov 15, 2018Use of Device Problem; Use of Device Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE PATIENT HAD A CATHETER WITH AN ADDITIONAL "RING" ON THE END INSERTED. UPON REMOVAL OF THE CATHETER, THE PATIENT ALLEGEDLY EXPERIENCED TRAUMA AND SELF-LIMITED BLEEDING. IT WAS ADVISED TO MONITOR THE PATIENT FOR ANY FURTHER COMPLICATIONS. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient; Patient Problem/Medical Problem

  MAUDE report 8075323 ↗
• MalfunctionOct 31, 2018Component Missing; Component Missing; Incomplete or Missing Packaging

  IT WAS REPORTED THAT THE FOLLOWING COMPONENTS; (1) DRAPE / (1) UNDERPAD / (1) FORCEPS / (5) RAYON BALLS / (1)LABEL / (1) POVIDONE-IODINE SOLUTION PACKET WERE MISSING FROM THE CATHETER TRAY PRIOR TO USE. NO MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: Diaphoresis; No Consequences Or Impact To Patient

  MAUDE report 8025525 ↗
• MalfunctionOct 22, 2018Component Missing

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

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

  MAUDE report 7993771 ↗
• MalfunctionOct 16, 2018Compatibility Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT COTTON BALLS WERE PACKAGED INSIDE THE TRAY INSTEAD OF THE SWAB STICKS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7971505 ↗

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