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Dover P4P16XSD (UDI 10884521029613)Recalls & reported problems

Cardinal Health, Inc. · 100% Silicone Silver-Hydrogel Coated Urine Meter Foley Tray,16 Fr/Ch (5.3 mm), 5 mL Catheter Pre-connected to 2000 mL Drainage Bag with Luer-Lock Sampling and Adhesive Catheter Securement · 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 10884521029613), received between Oct 3, 2016 and Oct 3, 2016 — classified as 1 malfunction.

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 Information1

Recent adverse event reports

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

  • MalfunctionOct 3, 2016Break

    IT WAS REPORTED TO COVIDIEN ON (B)(6) 2016 THAT A CUSTOMER HAD AN ISSUE WITH A URINARY CATHETER. THE CUSTOMER REPORTS THAT THE FOLEY CATHETER SNAPPED (BROKE) AFTER THEY PLACED IT AND TUGGED TO ENSURE PLACEMENT.

    Patient problems: No Information

    MAUDE report 5994926 ↗

Other Urinary Drainage Collection Kit devices

All Urinary Drainage Collection Kit devices →

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