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Dover FPP18ULRecalls & reported problems

Cardinal Health, Inc. · Drainage Bag with Catheter,18 Fr/Ch (6.0 mm), 5 mL Hydrogel Coated Catheter Pre-connected to 2000 mL Drainage Bag, Luer-Lock Sampling with Top Vent, Anti-Reflux Device, Drain Spout · Class 2

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10884521046733), received between Dec 17, 2020 and Dec 17, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Separation Problem” (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

  • Separation Problem1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

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

  • MalfunctionDec 17, 2020Separation Problem; Separation Problem

    THE CUSTOMER REPORTED THE CATHETER DETACHED FROM THE TUBING THAT LEADS TO THE BAG AND WAS FOUND TO BE LEAKING WHEN THE DIAPER WAS CHANGED. THERE WAS NO PATIENT HARM.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11029520 ↗

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