BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GOLD 3WAY SIL 30CC 18FR

    MDR report key: 3910111 · Received February 25, 2014

    Report

    Report Number
    8040412-2014-00044
    Event Type
    Malfunction
    Date Received
    February 25, 2014
    Date of Event
    November 27, 2013
    Report Date
    January 29, 2014
    Manufacturer
    TELEFLEX MALAYSIA
    Product Code
    KOD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE SAMPLE WAS REC'D BY THE MANUFACTURER, BUT THE INVESTIGATION IS STILL ON-GOING. THE DEVICE HISTORY RECORD WAS REVIEWED AND NO ISSUE THAT COULD HAVE CONTRIBUTED TO THE REPORTED FAILURE WAS NOTED. THE DEVICE WAS MANUFACTURED ACCORDING TO RELEASE SPECIFICATION.

    Description of Event or Problem · 1

    WHEN THE CATHETER WAS REMOVED, THE PATIENT FELT PAIN. WHEN THEY LOOKED AT THE CATHETER, THEY SAW A SORT OF BUBBLE OR BALLOON ON THE CATHETER, WHICH WAS NOT THE REGULAR BALLOON USED FOR ANCHORING THE CATHETER IN THE BLADDER. NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116755 GOLD 3WAY SIL 30CC 18FR 3-WAY FOLEY CATHETER KOD TELEFLEX MALAYSIA 13B03

    Patients

    Seq Age Sex Outcome Treatment
    1