Bard® Intermittent Female Catheter 015914Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00801741039027), received between May 11, 2017 and May 20, 2022 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Expiration Date Error” (3 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 20, 2022Expiration Date Error; Expiration Date Error

  IT WAS REPORTED THAT THE USER ENQUIRED REGARDING THE EXPIRY DATE OF THE FEMALE CATHETER PRODUCT SINCE IT HAD DIFFERENT DATES ON PACKAGING (05/2016 AND 11/2016) AND JDE SYSTEM (08/31/2026). LOT # NGFV2870 IN JDE IT SHOWED AS 30NOV2026 AND LOT #NGFV2874, IN JDE SHOWED AS 31AUG2026. PER ADDITIONAL INFORMATION RECEIVED ON 04MAY2022, THREE DIFFERENT LOTS WERE OBTAINED (LOT# NGFV2870, LOT #NGFV2874, LOT #NGEZ1598).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14455178 ↗
• MalfunctionMay 20, 2022Expiration Date Error; Expiration Date Error

  IT WAS REPORTED THAT THE USER ENQUIRED REGARDING THE EXPIRY DATE OF THE FEMALE CATHETER PRODUCT SINCE IT HAD DIFFERENT DATES ON PACKAGING (05/2016 AND 11/2016) AND JDE SYSTEM (08/31/2026). LOT # NGFV2870 IN JDE IT SHOWED AS 30NOV2026 AND LOT #NGFV2874, IN JDE SHOWED AS 31AUG2026. PER ADDITIONAL INFORMATION RECEIVED ON 04MAY2022, THREE DIFFERENT LOTS WERE OBTAINED (LOT# NGFV2870, LOT #NGFV2874, LOT #NGEZ1598).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14454919 ↗
• MalfunctionMay 20, 2022Expiration Date Error; Expiration Date Error

  IT WAS REPORTED THAT THE USER ENQUIRED REGARDING THE EXPIRY DATE OF THE FEMALE CATHETER PRODUCT SINCE IT HAD DIFFERENT DATES ON PACKAGING (05/2016 AND 11/2016) AND JDE SYSTEM (08/31/2026). AS PER THE ADDITIONAL INFORMATION RECEIVED ON 04MAY2022, THREE DIFFERENT LOTS WERE OBTAINED (LOT# NGFV2870, LOT #NGFV2874, LOT #NGEZ1598).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14454407 ↗
• MalfunctionNov 26, 2019Misassembled; Fluid/Blood Leak; Misassembled; Material Puncture/Hole

  IT WAS REPORTED THAT THE CATHETER HAD TWO HOLES INSTEAD OF ONE WHICH RESULTED IN A PATIENT EXPERIENCING A URINE LEAK. NO MEDICAL INTERVENTION WAS REPORTED.

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

  MAUDE report 9374900 ↗
• MalfunctionNov 13, 2019Difficult to Insert

  IT WAS REPORTED THAT THE PATIENT ALLEGED THE CATHETERS HURT AND CAUSED HER PAIN WHEN SHE INSERTED IT.

  Patient problems: Pain

  MAUDE report 9316194 ↗
• MalfunctionSep 16, 2019Product Quality Problem; Physical Resistance/Sticking; Product Quality Problem

  IT WAS REPORTED THAT THE CATHETERS WERE STICKY AND COULD NOT BE USED.

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

  MAUDE report 9072526 ↗
• MalfunctionNov 28, 2017Cut In Material

  IT WAS REPORTED THAT THE TIP OF THE CATHETER APPEARED TO BE CUT. THE COMPLAINANT REPORTED THAT THE PACKAGING WAS SEALED, BUT THE ROUNDED CATHETER TIP APPEARED TO BE MISSING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7065227 ↗
• MalfunctionMay 11, 2017Device Inoperable; Device Contamination with Chemical or Other Material

  IT WAS REPORTED BY AN EXPERIENCED USER THAT THERE WAS AN ALLEGED EXTREMELY STICKY SUBSTANCE ON THE CATHETERS. AFTER THROWING A FEW STRIPS OUT, USER BEGAN CHECKING OTHER BOXES. USER ALLEGEDLY FOUND A FEW BOXES THAT THE CATHETERS WERE ALL VERY VER STICKY AND UNUSABLE. THERE WAS NO STICKY SUBSTANCE ON THE BOXES OR THE CATHETER PACKAGING, AND WAS ONLY ON THE CATHETER ITSELF. THE USER HAD A COUPLE OF BOXES FROM THE 1990'S AND THE CATHETERS APPEARED TO STILL BE IN VERY GOOD CONDITION AND DID NOT BELIEVE THAT THIS PROBLEM WAS CAUSED BY THE AGE OF THE CATHETERS.

  Patient problems: No Information; No Patient Involvement

  MAUDE report 6559955 ↗