BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TEMPERATURE SENSING 14F CATHETER

    MDR report key: 3802848 · Received May 2, 2014

    Report

    Report Number
    1417592-2014-00044
    Event Type
    Injury
    Date Received
    May 2, 2014
    Date of Event
    March 18, 2014
    Report Date
    April 30, 2014
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Product Code
    NWR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CLINICIAN INSERTED A FOLEY CATHETER INTO A MALE PATIENT IN THE ICU. THREE ATTEMPTS WITH THREE SEPARATE CATHETERS WERE MADE. THE BALLOONS WERE INFLATED WITH FLUID AND IT WAS REPORTED THAT EACH CATHETER FELL OUT DUE TO A RUPTURED BALLOON. THE FOURTH CATHETER WAS INSERTED WITH NO ISSUE. NO SAMPLES WERE RETAINED FOR EVALUATION. THE CLINICIAN STATED NO INJURY RESULTED. THIS IS THE FIRST REPORTED ISSUE OF THIS NATURE FOR THIS CATHETER. A ROOT CAUSE HAS NOT BEEN DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THREE ATTEMPTS WERE MADE TO INSERT A CATHETER INTO A PATIENT AND EACH TIME THE BALLOON RUPTURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    263743 TEMPERATURE SENSING 14F CATHETER NWR MEDLINE INDUSTRIES, INC. 13VB2708

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other