Leg Bag 151932Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00801741050923), received between May 25, 2017 and Jul 27, 2021 — classified as 3 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Restricted 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 16, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryJul 27, 2021Restricted Flow rate; Restricted Flow rate

  IT WAS REPORTED THAT CUSTOMER DID NOT LIKE THE LEG BAGS. STATED THAT THE URINE DID NOT FLOW INTO THE LEG BAG AS EASY AS IT DID INTO THE DRAINAGE BAG. CUSTOMER FELT PRESSURE AND SWEATS WHEN USING THE LEG BAG AND BELIEVED THIS WAS DUE TO THE ANTI-REFLUX CHAMBER IN THE LEG BAG AND PREFERRED THE CHAMBER ON THE DRAINAGE BAGS. REPRESENTATIVE DISCUSSED CUSTOMER ABOUT TROUBLESHOOTING TIPS FOR VAPOR LOCKED DRAINAGE BAGS. RECOMMENDATIONS WERE TO EXERCISE BAG TO RELEASE VAPOR LOCK, CHECKING FOR KINKS, PROPER POSITION OF BAG AND TO ENSURE TUBING WAS NOT CLAMPED OFF. SUGGEST DISCONNECTING AND RECONNECTING BAG TO RELEASE VAPOR LOCK. BD USED A GAS TO STERILIZE THESE PRODUCTS, WHICH DRAWS AIR OUT CAUSING THE SIDES OF BAGS TO CLING TOGETHER. VAPOR LOCK CAN BE PARTIAL OR COMPLETE INTERRUPTION OF FLOW OF A FLUID. PER FOLLOW UP ON 01JUL2021, CUSTOMER STILL HAVING ISSUES WITH THE BAGS VAPOR LOCKING. ALSO STATED THAT THE LEG BAGS NEED SOMETHING THAT PREVENTS BACK FLOW LIKE THE 32OZ DRAIN BAGS. CUSTOMER EXPERIENCED A URINARY TRACT INFECTION, AND WAS TREATED BY THE DOCTOR WITH ANTIBIOTICS BECAUSE OF THE BACK FLOW FROM THE LEG BAG. CUSTOMER STATED THAT EVEN AFTER URINE WAS RELEASED FROM THE BAG, THERE WAS

  Patient problems: Urinary Tract Infection

  MAUDE report 12235349 ↗
• MalfunctionJul 15, 2021Restricted Flow rate; Restricted Flow rate

  IT WAS REPORTED THAT CUSTOMER DID NOT LIKE THE LEG BAGS. STATED THAT THE URINE DID NOT FLOW INTO THE LEG BAG AS EASY AS IT DID INTO THE DRAINAGE BAG. CUSTOMER FELT PRESSURE AND SWEATS WHEN USING THE LEG BAG AND BELIEVED THIS WAS DUE TO THE ANTI-REFLUX CHAMBER IN THE LEG BAG AND PREFERRED THE CHAMBER ON THE DRAINAGE BAGS. REPRESENTATIVE DISCUSSED CUSTOMER ABOUT TROUBLESHOOTING TIPS FOR VAPOR LOCKED DRAINAGE BAGS. RECOMMENDATIONS WERE TO EXERCISE BAG TO RELEASE VAPOR LOCK, CHECKING FOR KINKS, PROPER POSITION OF BAG AND TO ENSURE TUBING WAS NOT CLAMPED OFF. SUGGEST DISCONNECTING AND RECONNECTING THE BAG TO RELEASE VAPOR LOCK. BD USED A GAS TO STERILIZE THESE PRODUCTS, WHICH DRAWS AIR OUT CAUSING THE SIDES OF BAGS TO CLING TOGETHER. VAPOR LOCK CAN BE PARTIAL OR COMPLETE INTERRUPTION OF FLOW OF A FLUID. PER FOLLOW UP ON (B)(6) 2021, CUSTOMER STILL HAVING ISSUES WITH THE BAGS VAPOR LOCKING. ALSO STATED THAT THE LEG BAGS NEED SOMETHING THAT PREVENTS BACK FLOW LIKE THE 32OZ DRAIN BAGS. CUSTOMER EXPERIENCED A URINARY TRACT INFECTION, AND WAS TREATED BY THE DOCTOR WITH ANTIBIOTICS BECAUSE OF THE BACKFLOW FROM THE LEG BAG. CUSTOMER STATED THAT EVEN AFTER URINE WAS RELEASED FROM THE BAG, THERE

  Patient problems: Urinary Retention

  MAUDE report 12173234 ↗
• InjuryApr 17, 2019Microbial Contamination of Device; Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PATIENT HAVE DEVELOPED INFECTIONS FROM THE LEG BAG.

  Patient problems: Unspecified Infection

  MAUDE report 8522439 ↗
• InjuryFeb 1, 2019Unexpected Therapeutic Results; Patient-Device Incompatibility; Detachment of Device or Device Component; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE TUBING CONNECTED TO THE PATIENTS SUPRAPUBIC CATHETER WAS CAUSING BLISTERS ON THE PATIENTS ABDOMEN. REPORTEDLY, THE TUBING DID NOT STAY CONNECTED TO THE LEG BAG AND EASILY SEPARATED. NO MEDICAL INTERVENTION WAS REPORTED. PER ADDITIONAL INFORMATION RECEIVED FROM PATIENT'S WIFE VIA THE PHONE ON (B)(6) 2018, SHE ADVISED THAT SHE WAS TAKING THE PATIENT BACK TO A DERMATOLOGIST TO DETERMINE IF HE HAD AN INFECTION OR A SKIN SENSITIVITY TO THE TUBING MATERIAL. PER ADDITIONAL INFORMATION RECEIVED FROM PATIENT'S WIFE VIA THE PHONE ON (B)(6) 2019, SHE STATED THAT THE DERMATOLOGIST PERFORMED A BIOPSY ON (B)(6) 2019 AND THE RESULTS WILL BE AVAILABLE IN A COUPLE OF WEEKS.

  Patient problems: Patient Problem/Medical Problem; Skin Irritation

  MAUDE report 8297476 ↗
• MalfunctionJun 5, 2018Restricted Flow rate; Inflation Problem; Restricted Flow rate

  IT WAS REPORTED THAT THE PATIENT WAS NOT ABLE TO INFLATE THE BAG OR SEPARATE THE SIDES OF THE BAG PRIOR TO USE. THE PATIENT DID NOT USE THE LEG BAG.

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

  MAUDE report 7571337 ↗
• MalfunctionDec 19, 2017Kinked; Device Inoperable

  IT WAS REPORTED THAT THE INTAKE VALVE OF THE DRAIN BAG BECAME KINKED; URINE WOULD NOT DRAIN INTO THE BAG.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7129690 ↗
• MalfunctionMay 25, 2017Component Missing

  IT WAS REPORTED THAT THE LEG BAG WAS MISSING THE DRAIN BAG AND EXTENSION TUBING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6591814 ↗