Davol® Pediatric Cath Kit 0035640Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00801741045851), received between Jul 23, 2019 and Mar 4, 2026 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Disconnection” (5 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 4, 2026Disconnection; Fitting Problem

  IT WAS REPORTED THAT AN 8 FRENCH PEDIATRIC STRAIGHT CATHETER KIT HAD BEEN OPENED TO OBTAIN A URINE SAMPLE FROM THE PATIENT. THE CATHETER, WHICH SHOULD HAVE REMAINED SECURED IN THE COLLECTION TUBE UNTIL MANUALLY PULLED OUT, HAD BEEN LOOSE AND HAD FALLEN OUT OF THE COLLECTION TUBE DURING THE PROCEDURE. ANOTHER NURSE WHO HAD BEEN ASSISTING WITH HOLDING THE PATIENT HAD HELPED STABILIZE THE TUBE TO MAINTAIN STERILITY. NO HARM HAD REACHED THE PATIENT; HOWEVER, THE ISSUE HAD RESULTED IN AWKWARD POSITIONING AND A SLOWER PROCEDURE. TWO MORE 8 FRENCH PEDIATRIC STRAIGHT CATHETER KITS WITH THE SAME LOT NUMBER HAD BEEN OPENED. ONE HAD ALSO BEEN LOOSE, WITH THE CATHETER SLIPPING OUT OF THE COLLECTION TUBE, WHILE THE OTHER HAD SHOWN SOME RESISTANCE AND HAD NOT FALLEN OUT AS EASILY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24506155 ↗
• MalfunctionMar 4, 2026Disconnection

  IT WAS REPORTED THAT AN 8 FRENCH PEDIATRIC STRAIGHT CATHETER KIT HAD BEEN OPENED TO OBTAIN A URINE SAMPLE FROM THE PATIENT. THE CATHETER, WHICH SHOULD HAVE REMAINED SECURED IN THE COLLECTION TUBE UNTIL MANUALLY PULLED OUT, HAD BEEN LOOSE AND HAD FALLEN OUT OF THE COLLECTION TUBE DURING THE PROCEDURE. ANOTHER NURSE WHO HAD BEEN ASSISTING WITH HOLDING THE PATIENT HAD HELPED STABILIZE THE TUBE TO MAINTAIN STERILITY. NO HARM HAD REACHED THE PATIENT; HOWEVER, THE ISSUE HAD RESULTED IN AWKWARD POSITIONING AND A SLOWER PROCEDURE. TWO MORE 8 FRENCH PEDIATRIC STRAIGHT CATHETER KITS WITH THE SAME LOT NUMBER HAD BEEN OPENED. ONE HAD ALSO BEEN LOOSE, WITH THE CATHETER SLIPPING OUT OF THE COLLECTION TUBE, WHILE THE OTHER HAD SHOWN SOME RESISTANCE AND HAD NOT FALLEN OUT AS EASILY.

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

  MAUDE report 24506154 ↗
• MalfunctionSep 25, 2025Disconnection; Fitting Problem; Disconnection; Fitting Problem

  IT WAS REPORTED THAT THE CUSTOMER STATED THAT CATHETER KIT HAS DEFECT WHERE THE CATHETER FALLS OUT OF THE COLLECTION CONTAINER DURING THE PROCEDURE. THIS HAS CAUSED URINE TO SPILL OUT OF THE CONTAINER MID-COLLECTION, IN ONE INSTANCE VIOLATED THE STERILE FIELD, AND HAS RESULTED IN HAVING TO OPEN SEVERAL KITS FOR SOME PATIENTS. THEY PROVIDED TWO LOT NUMBER: NGJW2398 AND NGJV1962. CUSTOMER RESPONSE RECEIVED VIA EMAIL ON 16SEPT2025, IT WAS REPORTED THAT THERE WAS NO PATIENT IMPACT, THIS WAS A CONCERN THAT THERE WAS POSSIBILITY TO INVITE CONTAMINATION BASED ON PRIOR EXPERIENCE AND EVENTS. THEY WERE FOLLOWING THE MANUFACTURER¿S INSTRUCTIONS FOR USE, AND IT WAS FAILING, WOULD LEAN TOWARDS PULLING THE PRODUCT. THEY WOULD BE CONCERNED FOR SENSITIVE POPULATIONS (NEWBORNS, IMMUNOCOMPROMISED) AND RISK OF INFECTION, IN ADDITION TO THE ADDED DISCOMFORT. "THE CATHETER TUBING WAS PULLING FREE DURING THE COURSE OF NORMAL USE. THEY JUST SLIP RIGHT OUT. THIS DOES IMPACT THE ABILITY TO USE THE PRODUCT NORMALLY."

  Patient problems: Exposure to Body Fluids

  MAUDE report 23145099 ↗
• MalfunctionMay 27, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE PEDIATRIC CATHETER BROKE OFF, NOT SURE IF IT WAS BREAKING OFF IN THE PATIENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22088778 ↗
• MalfunctionJun 6, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT CUSTOMER HAD BEEN SEEING MULTIPLE CONCERNS ON BARD PEDIATRIC CATHETER KIT, WHERE THE STRAIGHT CATHETER KITS HAD FELL OUT OF THE COLLECTION CONTAINER. ADDITIONALLY, THEY HAD A NURSE ON A TRAVEL ASSIGNMENT, AND THEY WERE SEEING THE SAME ISSUE WITH THE SAME KITS. PER SAMPLE FORM RECEIVED ON (B)(6) 2024, IT WAS REPORTED THAT THE PATIENT NEEDED A CATHETER AND KIT WAS PULLED FROM THE CART, CATHETER TUBE SNAPPED IN HALF WHEN PULLED FROM COLLECTION TUBE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19475700 ↗
• MalfunctionNov 22, 2023Disconnection; Fitting Problem; Disconnection; Fitting Problem

  IT WAS REPORTED THAT THE PEDIATRIC CATHETER WAS SLIDING OUT TOO EASILY FROM THE COLLECTION CONTAINER, COMPROMISING STERILITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18191768 ↗
• MalfunctionOct 13, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE PHYSICIAN ORDERED A CATHETER TO BE CATHETERIZED ON THE 10 MONTHS OLD PATIENT. THEY PREPARED THE AREA, INSERTED THE CATHETER, THE CATHETER BROKE AWAY FROM THE PLASTIC CUP THAT CATCHES THE URINE. NO HARM TO THE PATIENT. SEVERAL OTHER CATHETER KITS WITH THE SAME LOT NUMBER WERE OPENED AND WERE NOTED TO HAVE THE SAME CONCERN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17930327 ↗
• MalfunctionSep 14, 2023Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT THE CUSTOMER HAD AN ISSUE WITH DAVOL PEDIATRIC CATHETER KIT. A FEW STAFF HAVE STATED THAT THE TUBE WAS TOO LOSE FOR THE OPENING OF THE COLLECTION TUBE. SO, THE TUBE THAT WAS INSERTED INTO THE PATIENT, THE SIZE OF THE FRENCH SEEMED TO BE NOT CORRECT FOR THE SIZE OF THE COLLECTION TUBE. ALSO STATED THAT THEY ORDERED WHAT THEY THOUGHT WERE STREP KITS USING THE CODE FOR THE PROMOTION, BUT GOT COVID TESTS. PER FOLLOW UP VIA PHONE ON 06SEP2023, THE STAFF JUST STATED THAT SOMETHING WAS DIFFERENT, AND THE HANDLING OF THE TUBE WAS DIFFICULT COMPARED TO HOW IT USUALLY WAS. PER ADDITIONAL INFORMATION RECEIVED ON 07SEP2023, ALL REPORTED INFORMATION WAS CAPTURED FROM THE CUSTOMER. THE ISSUE THEY HAD WAS WITH THE FITTING OF THE TUBE FROM WHAT WAS INITIALLY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17745327 ↗
• MalfunctionSep 8, 2023Disconnection; Disconnection

  IT WAS REPORTED THAT THE NURSE WAS USING 8 FRENCH PEDIATRIC CATHETER KIT ON A 10 MONTH OLD BABY IN ORDER TO RULE OUT URINARY TRACT INFECTION. STERILE CONTAINER FELL OFF CATHETER ON ITS OWN DURING PROCEDURE. ALSO, LUBE WAS NEEDED SCISSORS TO BE OPENED BECAUSE THE PERFORATIONS ON LUBE WOULD NOT LET IT OPEN. THIS CAUSED URINE TO NOT TO BE COLLECTED AND INTERVENTION WAS NEEDED. THIS CAUSED A URINE BAG TO BE PLACED, BUT IF THE URINE COLLECTED FROM BAG HAS AN ABNORMAL DIPSTICK RESULT, ANOTHER CATHETER WOULD BE NEEDED TO BE PERFORMED. ANOTHER CATHETER KIT WITH THE SAME LOT NUMBER WAS OPENED AND HAD THE SAME MALFUNCTIONS AS THE KIT USED ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17710361 ↗
• MalfunctionSep 8, 2023Difficult to Open or Remove Packaging Material; Difficult to Open or Remove Packaging Material

  IT WAS REPORTED THAT THE NURSE WAS USING 8 FRENCH PEDIATRIC CATHETER KIT ON A 10 MONTH OLD BABY IN ORDER TO RULE OUT URINARY TRACT INFECTION. STERILE CONTAINER FELL OFF CATHETER ON ITS OWN DURING PROCEDURE. ALSO, LUBE WAS NEEDED SCISSORS TO BE OPENED BECAUSE THE PERFORATIONS ON LUBE WOULD NOT LET IT OPEN. THIS CAUSED URINE TO NOT TO BE COLLECTED AND INTERVENTION WAS NEEDED. THIS CAUSED A URINE BAG TO BE PLACED, BUT IF THE URINE COLLECTED FROM BAG HAS AN ABNORMAL DIPSTICK RESULT, ANOTHER CATHETER WOULD BE NEEDED TO BE PERFORMED. ANOTHER CATHETER KIT WITH THE SAME LOT NUMBER WAS OPENED AND HAD THE SAME MALFUNCTIONS AS THE KIT USED ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17710359 ↗
• MalfunctionJan 7, 2022Inaccurate Flow Rate; Inaccurate Flow Rate

  IT WAS REPORTED THAT INTERMITTENT CATHETERS WERE USED ON MULTIPLE PATIENTS AND HAVE DISCOVERED THEY WERE DEFECTIVE. STATED THAT THE URINE DRAINS FROM THE SMALL CATHETER INTO THE CLEAR RESERVOIR DURING CATHETERIZATION, BUT BEFORE THE CATHETER WAS PULLED FROM THE PATIENT, THE URINE LEFT THE RESERVOIR AND WENT BACK INTO THE BLADDER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13196227 ↗
• MalfunctionJul 23, 2019Component Missing

  IT WAS REPORTED THAT THE KIT WAS MISSING THE SWAB-STICKS.

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

  MAUDE report 8817070 ↗