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Medline UROT1001Recalls & reported problems

Medline Industries, Inc. · BUDDY THE BRAVE ADD A CATH KIT · Class 2

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10888277879102), received between Apr 16, 2018 and Apr 16, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Break” (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

  • Break1

Patient problems

  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryApr 16, 2018Break

    IT WAS REPORTED THAT "THE FOLEY TUBING BROKE WHILE BARELY TILTING PATIENT."

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 7432145 ↗

Other Catheter care tray 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.