BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FOLEY CATHETER, 16FR SILICONE

    MDR report key: 3961011 · Received May 23, 2014

    Report

    Report Number
    1417592-2014-00054
    Event Type
    Injury
    Date Received
    May 23, 2014
    Date of Event
    April 22, 2014
    Report Date
    May 22, 2014
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Product Code
    NWR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CATHETER FELL OUT AND THE BALLOON WAS FOUND TO BE RUPTURED. THERE WAS NO PT INJURY AND A NEW CATHETER WAS NOT INSERTED. NO MEDICAL INTERVENTION WAS INDICATED. THE SAMPLE WAS RETURNED AND EVALUATED. THE BALLOON HAD A CLEAN TEAR. IT IS NOT KNOWN HOW MUCH FLUID WAS USED TO INFLATE THE BALLOON. WE CANNOT RULE OUT OVER-INFLATION OF THE CATHETER BALLOON AS A POTENTIAL ROOT CAUSE FOR THE RUPTURE.

    Description of Event or Problem · 1

    THE FOLEY CATHETER FELL OUT AND THE BALLOON WAS FOUND TO BE RUPTURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309221 FOLEY CATHETER, 16FR SILICONE NWR MEDLINE INDUSTRIES, INC. 13WB3883

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other