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Bard® Urinary Drainage Bag 603402Recalls & reported problems

C. R. Bard, Inc. · Bard® Urinary Drainage Bag · Class 2

Adverse event reports
2
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741029523), received between Jul 25, 2018 and Sep 4, 2020 — classified as 2 malfunctions.

The most frequently reported specific device problem is “No Flow” (1 report).

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

  • No Flow1
  • Output Problem1
  • Restricted Flow rate1

Patient problems

  • Insufficient Information1
  • No Consequences Or Impact To Patient1
  • No Information1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • MalfunctionSep 4, 2020Output Problem

    IT WAS REPORTED THAT THE DRAINAGE BAGS WAS NOT DRAINING.

    Patient problems: Insufficient Information

    MAUDE report 10497344 ↗
  • MalfunctionJul 25, 2018Restricted Flow rate; No Flow; Restricted Flow rate

    IT WAS REPORTED THAT URINE WOULD NOT FLOW INTO THE DRAIN BAG.

    Patient problems: No Consequences Or Impact To Patient; No Information

    MAUDE report 7719181 ↗

Other COLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER devices

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.