Davol® Infant Cath Kit 0035630Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00801741045844), received between Jan 22, 2018 and Jun 25, 2025 — classified as 3 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Inaccurate Flow Rate” (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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 25, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT INQUIRER STATED A NURSE INSERTED THE 5FR FOLEY CATHETER FROM CATHETER KIT 0035630 BY THE DRAINAGE SIDE RATHER THAN THE PROPER INSERTION SIDE. THEY STATED WHEN PULLED IT OUT OF THE TUBE, IT GOT TURNED AROUND AND BOTH ENDS LOOKED SIMILAR. WHAT COULD THEY DID GOING FORWARD TO PREVENT THAT. INQUIRER STATED THEY DID GET URINE OUTPUT, SO IT DID WORK OUT STILL. DISCUSSED INSTRUCTION FOR USE WITH INQUIRER: PUT ON STERILE GLOVES. REMOVE PROTECTIVE SHEATH FROM CATHETER AND PULL CATHETER OUT OF CENTRIFUGE TUBE TO DESIRED LENGTH. LAY TUBE ASSEMBLY ON THE STERILE FIELD. SUGGESTED TO KEEP THE CATHETER WITH THE DRAINAGE END NEAR THE TUBE IF SEPARATED IN ORDER TO HAVE THE DRAINAGE END IDENTIFIED. FORWARDED TO COMPLAINTS FOR DOCUMENTATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22331759 ↗
• MalfunctionNov 14, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE URINE CATHETER FOR STRAIGHT CATH WAS BENT WHEN PACKAGE WAS OPENED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20683117 ↗
• InjuryDec 22, 2023Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT HOW MUCH OF THE FOLEY CATHETER SHOULD BE LEFT IN THE TUBE WHEN USING IT TO OBTAIN A URINE SPECIMEN. AND REPORTED THAT THE INTERMITTENT CATHETER SOMETIMES A SMALLER SIZE COULD BE USED DUE TO IT JUST BEING FOR SPECIMEN COLLECTION. THE POSSIBLE LEAKING AROUND THE CATHETER WAS NOT AS GREAT OF A CONCERN IF NOT BEING PLACED AS AN INDWELLING. AND REPORTED THAT 5 FRENCH CATHETER KITS WERE VERY SECURE IN THE COLLECTION TUBE AND SOME RESISTANCE WHEN PULLING OUT THE CATHETER, WHILE THE 8 FRENCH FEMALE CATHETER KITS HAD VERY LITTLE RESISTANCE WHEN PULLING OUT THE CATHETER. IT DID NOT FALL OUT ON ITS OWN BUT TOOK VERY LITTLE PULL TO HAVE IT BECOME COMPLETELY DISLODGED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18388640 ↗
• MalfunctionOct 11, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THE NURSE HAD SOME INFANT CATHETER KITS THAT DAY THE CATHETER WAS SPIRALED AND UNABLE TO BE USED. CUSTOMER HAD TO OPEN 3 KITS TO FIND A GOOD ONE AND ALSO FOUND A BLACK HAIR IN ONE OF THE KITS THAT WAS SUPPOSED TO BE STERILE. THE CUSTOMER STILL HAD ONE KIT SEALED WHERE THEY CAN SEE THE CURLED TUBING AND ANOTHER TUBE THAT IS CURLED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15579530 ↗
• MalfunctionOct 11, 2022Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE NURSE HAD SOME INFANT CATHETER KITS THAT DAY THE CATHETER WAS SPIRALED AND UNABLE TO BE USED. CUSTOMER HAD TO OPEN 3 KITS TO FIND A GOOD ONE AND ALSO FOUND A BLACK HAIR IN ONE OF THE KITS THAT WAS SUPPOSED TO BE STERILE. THE CUSTOMER STILL HAD ONE KIT SEALED WHERE THEY CAN SEE THE CURLED TUBING AND ANOTHER TUBE THAT IS CURLED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15579385 ↗
• MalfunctionNov 22, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE BABY WAS INSERTED WITH A STRAIGHT CATHETER AND THE TUBING LEAKED. THIS RESULTED IN CONTAMINATED URINE AND THE BABY NEEDED ANOTHER STRAIGHT CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12853389 ↗
• MalfunctionNov 2, 2020Component Missing; Component Missing

  IT WAS REPORTED THAT THE IODINE SWABS WERE MISSING IN THE KIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement

  MAUDE report 10773518 ↗
• MalfunctionJun 24, 2019Short Fill; Short Fill; Moisture or Humidity Problem

  IT WAS REPORTED THAT THE BETADINE IN THE INFANT CATH KIT WAS DRIED UP UPON OPENING THE SEALED PACKET. NO MEDICAL INTERVENTION WAS REPORTED.

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

  MAUDE report 8727920 ↗
• InjuryNov 27, 2018Use of Device Problem; Use of Device Problem; Improper or Incorrect Procedure or Method; Device Markings/Labelling Problem

  IT WAS REPORTED THAT TWO INFANT CATHETER KITS WERE SENT, RECEIVED AND USED ON ONE INFANT WITHOUT THE POVIDONE-IODINE INCLUDED. REPORTEDLY, AS A RESULT, THE INFANT CONTRACTED A URINARY TRACT INFECTION. THE UTI WAS TREATED WITH ANTIBIOTICS. IT WAS NOTED THAT THE YELLOW LABEL INDICATING THE ABSENCE OF THE POVIDONE-IODINE WAS ADHERED TO THE PACKAGING. HOWEVER, THE NURSE DID NOT NOTICE THE LABEL UPON FIRST LOOKING AT THE PACKAGE.

  Patient problems: Patient Problem/Medical Problem; Urinary Tract Infection

  MAUDE report 8108877 ↗
• InjuryOct 10, 2018Patient-Device Incompatibility; Improper or Incorrect Procedure or Method; Component Missing; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PATIENT DEVELOPED A UTI AFTER USE OF THE CATHETER. THE CATHETER KIT WAS MISSING THE IODINE SWAB STICKS; AN IODINE REPLACEMENT WAS NOT USED PRIOR TO USE OF THE CATHETER. REPORTEDLY THE CATHETER KIT DID CONTAIN A WARNING STICKER EXPLAINING THAT THE SWAB STICKS WOULD BE MISSING BUT THIS WAS NOT NOTICED UNTIL AFTER THE CATHETER HAD BEEN USED.

  Patient problems: Urinary Tract Infection

  MAUDE report 7953708 ↗
• MalfunctionSep 12, 2018Gel Leak; Leak/Splash; Tear, Rip or Hole in Device Packaging; Gel Leak

  IT WAS REPORTED THAT THE BETADINE PACKAGE LEAKED ONTO THE CONTENTS OF THE TRAY.

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

  MAUDE report 7868632 ↗
• MalfunctionAug 29, 2018Material Deformation; Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE TIP OF THE INFANT CATHETER BECAME KNOTTED WHILE INSERTED IN THE PATIENT'S URETHRA. THE UROLOGIST WAS CALLED TO REMOVE THE CATHETER, WHICH ALLEGEDLY RESULTED IN TRAUMA TO THE PATIENT'S URETHRA. PER FOLLOW UP WITH NURSE MANAGER (B)(6) VIA PHONE ON (B)(6) 2018, THE TRAUMA TO THE PATIENT'S URETHRA INVOLVED SELF-LIMITED BLEEDING. NO MEDICAL TREATMENT REPORTED. PER ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON (B)(6) 2018 FROM (B)(6), THE UROLOGIST GAVE THE CATHETER A FIRM TUG TO REMOVE IT FROM THE PATIENT'S URETHRA.

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

  MAUDE report 7826037 ↗
• MalfunctionJul 10, 2018Inaccurate Flow Rate; No Flow; Inaccurate Flow Rate

  IT WAS REPORTED THAT URINE DID NOT DRAIN WHEN THE PEDIATRIC CATHETER WAS INSERTED TO COLLECT A URINE SAMPLE. HOWEVER, WHEN THE CATHETER WAS REMOVED, THE PATIENT RELEASED URINE.

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

  MAUDE report 7675512 ↗
• MalfunctionJul 10, 2018Inaccurate Flow Rate; No Flow; Inaccurate Flow Rate

  IT WAS REPORTED THAT URINE DID NOT DRAIN WHEN THE PEDIATRIC CATHETER WAS INSERTED TO COLLECT A URINE SAMPLE. HOWEVER, WHEN THE CATHETER WAS REMOVED THE PATIENT RELEASED URINE.

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

  MAUDE report 7675450 ↗
• MalfunctionJul 10, 2018Inaccurate Flow Rate; No Device Output; Inaccurate Flow Rate

  IT WAS REPORTED THAT URINE DID NOT DRAIN WHEN THE PEDIATRIC CATHETER WAS INSERTED TO COLLECT A URINE SAMPLE. HOWEVER, WHEN THE CATHETER WAS REMOVED, THE PATIENT RELEASED URINE.

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

  MAUDE report 7675447 ↗
• MalfunctionJul 3, 2018Break

  IT WAS REPORTED THAT THE PEDIATRIC CATHETER CAME APART.

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

  MAUDE report 7658614 ↗
• MalfunctionJan 31, 2018Leak/Splash

  IT WAS REPORTED THAT THE PACKET OF BETADINE SWAB LEAKED WITHIN THE KIT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7231142 ↗
• MalfunctionJan 22, 2018Device Operates Differently Than Expected

  IT WAS REPORTED THAT THE CATHETER WAS NOT DRAINING PROPERLY. THE COMPLAINANT ALLEGED THAT THE URINE WAS COMING DOWN THE SIDE OF THE CATHETER AND NOT THROUGH THE TUBE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7210555 ↗