Leg Bag 150102Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00801741050725), received between Mar 20, 2019 and Nov 29, 2023 — classified as 2 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Component Missing” (4 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 16, 2026.

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 29, 2023Restricted Flow rate; Restricted Flow rate

  IT WAS REPORTED THAT CUSTOMER HAD TAKEN THE CAP OFF AND YOU SHOULD BE ABLE TO BE STANDING OR WHATEVER AND HAVE THE BAG DRAIN. SOMETHING WAS BLOCKED AND IT WAS NOT DRAINING. THEY COULD NOT GET ANYTHING TO POUR OUT OF THE DRAIN BAG. IT WAS VERY TIGHT. THEY COULD LOOK DOWN IT AND SEE INTO THE BAG AND SEE THE URINE. THEY TRIED TO PUT AN OBJECT DOWN IN THERE AND IT FELT LIKE IT WAS BLOCKED. THEY DID NOT WANT TO PIERCE IT AND THEN THEY WOULD NOT BE ABLE TO CONTINUE TO USE THE BAG. THE PATIENT JUST GOT HOME FROM THE HOSPITAL LAST NIGHT. THIS WAS THE ONLY BAG THEY GAVE US. THEY HAD NO OTHER BAGS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18228767 ↗
• InjuryMar 15, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE CUSTOMER USED THE LEG BAG ON THEIR LEFT LEG, THERE WAS A FAULTY VALVE AT THE BOTTOM THAT DRIPPED URINE ON THEIR LEG. THERE WAS A SCREW ON VALVE AND WHEN IT WAS TURNED OFF IT STILL LEAKED. WHEN THEY WENT TO THE BATHROOM TO CLEAN IT UP, THE URINE DRIPPING DOWN THEIR LEG CAUSED THE PATIENT TO SLIP AND FALL. AS A RESULT, THE PATIENT WAS BADLY INJURED AND WAS HOSPITALIZED FOR ROUGHLY 4-5 DAYS. CUSTOMER STILL HAD CATHETER BAG THAT COULD BE SHIPPED IN FOR INVESTIGATION. PER CUSTOMER VIA PHONE (B)(6) 2023, PATIENT IS STILL BEING TREATED FOR INJURY FROM THE FALL. STATED THE DRAIN BAG HAD BEEN IN USE FOR THE DAY AT THE TIME THE LEAK OCCURRED. CUSTOMER STATES THAT THIS HAS HAPPENED ONE TIME.

  Patient problems: Fall

  MAUDE report 16548019 ↗
• MalfunctionDec 28, 2022Partial Blockage; Partial Blockage

  IT WAS REPORTED THAT THE LEG BAG HAD ALWAYS BEEN TAPERED AND FITTED INTO CATHETERS. THE PATIENT STATED THERE WAS SOMETHING IN THE LEG BAG BLOCKING IT FROM DRAINING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16061251 ↗
• MalfunctionJul 25, 2022Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT THE PATIENT WAS HAVING ISSUES WITH LEG BAG TUBING TWISTING AND GETTING KINK IN TUBING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15093369 ↗
• MalfunctionNov 25, 2021Component Missing; Component Missing

  IT WAS REPORTED THAT THE LEG BAG WAS NOT WORKING. THE PATIENT HAD BEEN USING THIS PRODUCT FOR LESS THAN 90 DAYS. PER ADDITIONAL INFORMATION RECEIVED VIA LIBERATOR ON 26OCT2021, IT WAS INDICATED THAT THE LEG BAGS WERE NOT PROVIDED WITH GREEN TUBING OR CONNECTOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12874101 ↗
• MalfunctionNov 23, 2021Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT THE DRAIN BAG GREEN TUBE WAS MISSING FROM WHERE IT WOULD BE ATTACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12859989 ↗
• MalfunctionNov 9, 2021Component Missing; Component Missing

  IT WAS REPORTED THAT THE DRAIN BAG DID NOT COME WITH GREEN TUBING OR CONNECTOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12780191 ↗
• MalfunctionOct 20, 2021Component Missing; Component Missing

  IT WAS REPORTED THAT THE TUBING WAS MISSING FROM THE LEG BAGS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12665983 ↗
• InjuryJan 5, 2021Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT THE PATIENT HAD EXPERIENCED BLADDER INFECTION AS EVERYTHING DRAINED DOWN TO THE TUBE. THE PATIENT BELIEVED THAT BEING TILTED BACK IN THE WHEELCHAIR MIGHT HAVE BEEN PART OF THE PROBLEM. IT IS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED FOR THE BLADDER INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 11120888 ↗
• MalfunctionMar 19, 2020Deformation Due to Compressive Stress

  IT WAS REPORTED THAT THE CUSTOMER DID NOT LIKE BARD LEG BAGS. PER ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER CONTACT VIA PHONE ON 26FEB2020, THE TUBING ON THE DRAIN BAG KINKED DURING USE.

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

  MAUDE report 9853188 ↗
• MalfunctionSep 17, 2019Partial Blockage; Obstruction of Flow; Partial Blockage

  IT WAS REPORTED THAT THERE WAS A CLEAR THIN FILM OF PLASTIC MATERIAL OVER THE END OF THE DRAIN VALVE BLOCKING ANY FLUID FROM BEING DRAIN. A NEW BAG WAS PLACED AND IT DRAIN PROPERLY. NO MEDICAL INTERVENTION WAS REPORTED.

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

  MAUDE report 9075942 ↗
• MalfunctionAug 22, 2019Misassembled; Misassembled

  IT WAS REPORTED THAT THE LEG BAG HAD NO WAY TO DRAIN OR HOLD URINE INSIDE. ALLEGEDLY THERE WAS NO OPENING AT ONE END.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8922563 ↗
• MalfunctionMar 20, 2019Component Missing

  IT WAS REPORTED THAT THE LEG BAG ARRIVED WITHOUT TUBING.

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

  MAUDE report 8438599 ↗