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Medline DYND160418Recalls & reported problems

Medline Industries, Inc. · TRAY,FOLEY,ERASE CAUTI,SILV,LF,18FR 10ML · Class 2

Data updated Oct 18, 2026 from official FDA records · Editorial policy

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 10884389096086), received between Nov 7, 2018 and Nov 7, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Leak/Splash” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Device problems

  • Leak/Splash1

Patient problems

  • No Consequences Or Impact To Patient1

Recent adverse event reports

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

  • MalfunctionNov 7, 2018Leak/Splash

    IT WAS REPORTED THAT AN UNIDENTIFIED NUMBER OF FOLEY CATHETERS "LEAK URINE AFTER BEING INSERTED FOR JUST THREE DAYS."

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8046563 ↗

Other Catheter care tray devices

All Catheter care tray devices →

Sources and updates

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