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Medline DYND160514Recalls & reported problems

Medline Industries, Inc. · TRAY,ERASE CAUTI,URN MTR,SILV,LF,14FR10M · Class 2

Adverse event reports
2
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884389287729), received between Oct 4, 2018 and Oct 5, 2018 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Component Missing” (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

  • Component Missing1
  • Leak/Splash1

Patient problems

  • No Consequences Or Impact To Patient1
  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

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

  • InjuryOct 5, 2018Leak/Splash

    IT WAS REPORTED THAT AN INDWELLING CATHETER DRAINAGE BAG AT THE UROMETER CONNECTION POINT WAS NOTED TO BE LEAKING AROUND THE UROSEAL AGAINST THE BAG.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 7938955 ↗
  • MalfunctionOct 4, 2018Component Missing

    IT WAS REPORTED THAT THE TWIST VALVE ON THE URINE METER (THAT WAS PRE-CONNECTED TO THE FOLEY CATHETER) WAS MISSING.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 7934968 ↗

Other Catheter care tray devices

All Catheter care tray devices →

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