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Medline DYND160816Recalls & reported problems

Medline Industries, Inc. · TRAY,ERASE CAUTI,URN MTR,SILI,16FR10ML · Class 2

Adverse event reports
6
Deaths reported
0
Injuries reported
5
Recalls naming it
0

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10884389286296), received between Sep 29, 2021 and Jul 26, 2023 — classified as 5 injuries, 1 malfunction.

The most frequently reported specific device problem is “Fluid/Blood Leak” (3 reports).

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

  • Fluid/Blood Leak3
  • Appropriate Device Problem Term/Code Not Available1
  • Leak/Splash1
  • Material Disintegration1

Patient problems

  • Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available5
  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

  • InjuryJul 26, 2023Fluid/Blood Leak; Fluid/Blood Leak

    ACCORDING TO THE FACILITY ON (B)(6) 2023 THE FOLEY CATHETER BALLOON WAS NOTED TO BE LEAKING.

    Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

    MAUDE report 17396262 ↗
  • InjuryJul 26, 2023Fluid/Blood Leak; Fluid/Blood Leak

    ACCORDING TO THE FACILITY ON 07/07/23 THE FOLEY CATHETER BALLOON WAS NOTED TO BE LEAKING.

    Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

    MAUDE report 17396124 ↗
  • InjuryJul 26, 2023Fluid/Blood Leak; Fluid/Blood Leak

    ACCORDING TO THE FACILITY ON (B)(6) 2023 THE FOLEY CATHETER BALLOON WAS NOTED TO BE LEAKING.

    Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

    MAUDE report 17396034 ↗
  • InjuryJan 23, 2023Leak/Splash; Leak/Splash

    ACCORDING TO THE FACILITY ON (B)(6) 2023, "A REGISTERED NURSE NOTED LEAKING WHEN MOVING THE UROMETER BAG FROM STERILE CONTAINER TO HANG ON BED".

    Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

    MAUDE report 16229544 ↗
  • InjurySep 6, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

    ACCORDING TO THE FACILITY ON (B)(6) 2022 A 16FR SILICONE FOLEY CATHETER WAS PLACED PER PHYSICIAN. PER THE FACILITY URINE WAS RETURNED, BUT THE CATHETER WAS MET WITH RESISTANCE AND WAS UNABLE TO INSERT TO BIFURCATION AS PER FACILITY TRAINING. THE FOLEY CATHETER WAS REMOVED AND A 14FR FOLEY CATHETER WAS INSERTED WITHOUT DIFFICULTY.

    Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

    MAUDE report 15365063 ↗
  • MalfunctionSep 29, 2021Material Disintegration

    IT WAS REPORTED; "THE FOLEY BALLOON DISINTEGRATED." A NEW FOLEY CATHETER WAS REINSERTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12550189 ↗

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