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Leg Bag 150332Recalls & reported problems

C. R. Bard, Inc. · Dispoz-A-Bag, Leg Bag with Flip-Flo Drainage Valve and Two Latex Leg Straps, Large (32oz). · Class 1

Data updated Oct 13, 2026 from official FDA records · Editorial policy

Adverse event reports
4
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00801741050800), received between Dec 28, 2018 and Jun 14, 2021 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Restricted Flow rate” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Restricted Flow rate4
  • Backflow1
  • Inaccurate Flow Rate1
  • Leak/Splash1
  • No Flow1

Patient problems

  • No Consequences Or Impact To Patient3
  • No Known Impact Or Consequence To Patient3
  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJun 14, 2021Restricted Flow rate; Restricted Flow rate

    IT WAS REPORTED THAT THE DRAIN BAG WAS NOT OPENING ENOUGH TO LET THE WATER IN. IT WAS FURTHER MENTIONED THAT THE USER TRIED TO PUT THE WATER IN, AND IT PILED OVER ON THE TOP. PER FOLLOW-UP CALL ON 20MAY2021, IT WAS REPORTED THAT THE DRAIN BAGS THAT HAD A PROBLEM WITH THE FLUTTER VALVE AND WAS NOT ALLOWING THE WATER TO PASS THROUGH.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11996863 ↗
  • MalfunctionMay 20, 2019Restricted Flow rate; Backflow; Restricted Flow rate; Leak/Splash

    IT WAS REPORTED THAT URINE WAS BACKING UP INTO THE CATHETER AND AS A RESULT CAUSED LEAKAGE INSTEAD OF DRAINING INTO THE BAG. NO MEDICAL INTERVENTION WAS REPORTED.

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

    MAUDE report 8624439 ↗
  • MalfunctionJan 31, 2019Restricted Flow rate; Inaccurate Flow Rate; Restricted Flow rate

    IT WAS REPORTED THAT URINE WOULD STOP DRAINING INTO THE LEG BAG AFTER THE LEG BAG WAS HALF-WAY FILLED WITH URINE. NO MEDICAL INTERVENTION WAS REPORTED.

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

    MAUDE report 8293491 ↗
  • MalfunctionDec 28, 2018Restricted Flow rate; Restricted Flow rate; No Flow

    IT WAS REPORTED THAT THE URINE BACKED UP IN THE LEG BAG TUBING AND WOULD NOT DRAIN INTO THE BAG.

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

    MAUDE report 8204593 ↗

Other BAG, URINE COLLECTION, LEG, FOR EXTERNAL USE, STERILE devices

All BAG, URINE COLLECTION, LEG, FOR EXTERNAL USE, STERILE devices →

Sources and updates

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