Davol® Female Cath Kit 0035720Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00801741045837), received between Aug 22, 2018 and Nov 5, 2025 — classified as 3 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Disconnection” (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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 5, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE HOSPITAL USER STATED THAT THEY WERE GIVEN THE PACKAGE OF A DEFECTIVE BARD FEMALE CATHETER KIT 8 FR., SKU 0035720 FROM THEIR EMERGENCY DEPARTMENT. THEY MENTIONED THAT THE CATHETER TUBE WAS BROKEN IN HALF, BUT THEY DID NOT KEEP THE PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23480137 ↗
• MalfunctionApr 3, 2025Use of Device Problem; Fitting Problem; Use of Device Problem; Fitting Problem

  IT WAS REPORTED THAT THE CATHETER TUBE THAT GOES INTO THE PATIENT WAS LOOSER IN SOME DEVICES THAN OTHERS, CAUSING IT TO EASILY SLIDE OUT OF THE COLLECTIONS CONTAINER AND POTENTIALLY BE RETAINED IN A PATIENT. THEY HAVE TESTED 3 AND 2 WERE LOOSE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21761209 ↗
• InjuryMar 6, 2025Disconnection; Disconnection

  IT WAS REPORTED THAT CATHETER WAS SEPARATED FROM FEMALE CATHETER KIT COLLECTION TUBING. CATHETER WAS STUCK IN PATIENT FOR MULTIPLE DAYS AND NEEDED TO BE SURGICALLY REMOVED.

  Patient problems: Foreign Body In Patient

  MAUDE report 21536181 ↗
• MalfunctionFeb 25, 2025Disconnection; Disconnection

  IT WAS REPORTED THAT THE FEMALE CATHETER KIT TUBE THAT GONE INTO THE PATIENT WAS LOOSER IN SOME DEVICES THAN OTHERS, CAUSING IT TO EASILY SLIDE OUT OF THE COLLECTIONS CONTAINER AND POTENTIALLY BE RETAINED IN A PATIENT. THEY HAD TESTED THREE AND TWO WERE LOOSE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21462161 ↗
• MalfunctionJan 3, 2023Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT THE SWAB STICKS WERE DRY AND WHITE, AS IF THE POVIDONE-IODINE SOLUTION HAD NEVER BEEN ADDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16090877 ↗
• MalfunctionNov 9, 2022Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT A PATIENT'S NURSE WAS COMPLETING IN AND OUT OF FEMALE CATHETER AND THE CATHETER BROKE WHILE STILL IN THE PATIENT. STATED THAT THE NURSE WAS ABLE TO HOLD ONTO BOTH PIECES TO AVOID THE BROKEN PIECE GOING UP INTO THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 15758548 ↗
• InjuryDec 21, 2018Misassembled; Misassembled; Unsealed Device Packaging

  IT WAS REPORTED THAT THE GLOVES INSIDE OF THE FEMALE CATHETER KIT WERE NOT WRAPPED UP IN PAPER LIKE THEY USUALLY ARE, WHICH CAUSED THE GLOVES TO FALL OUT OF THE TRAY ONTO A NON-STERILE SURFACE ONCE THE TRAY WAS OPENED. ALLEGEDLY, THIS ISSUE CAUSED THERE TO BE CATHETER ASSOCIATED INFECTIONS. THERE WAS NO INFORMATION AVAILABLE REGARDING THE SPECIFIC TREATMENT PROVIDED.

  Patient problems: Pulmonary Infarction; Unspecified Infection

  MAUDE report 8189542 ↗
• InjuryDec 21, 2018Contamination /Decontamination Problem; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE GLOVES INSIDE OF THE FEMALE CATHETER KIT WERE STICKING TO EACH OTHER, WHICH RESULTED IN ONE OF THE GLOVES FALLING OUT OF THE TRAY ONTO A NON-STERILE SURFACE. THE COMPLAINANT REPORTED THAT THE ISSUE COULD BE CONTRIBUTING TO CATHETER ASSOCIATED INFECTIONS. PER FOLLOW UP WITH THE COMPLAINANT BY PHONE ON (B)(6) 2018 IT WAS NOTED THAT UTIS WERE DIAGNOSED BUT THERE WAS NO INFORMATION AVAILABLE ON THE SPECIFIC TREATMENT PROVIDED.

  Patient problems: Urinary Tract Infection

  MAUDE report 8189522 ↗
• MalfunctionAug 22, 2018Component Missing

  IT WAS REPORTED THAT THE CATHETER WAS MISSING FROM THE FEMALE CATHETER KIT.

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

  MAUDE report 7804701 ↗