BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIMPLASTIC SUPRAPUBIC 16F

    MDR report key: 4791395 · Received May 21, 2015

    Report

    Report Number
    8040412-2015-00100
    Event Type
    Malfunction
    Date Received
    May 21, 2015
    Date of Event
    April 1, 2015
    Report Date
    April 22, 2015
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    KOD
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HISTORY RECORD WAS REVIEWED. NO ISSUE THAT COULD CONTRIBUTE TO THE REPORTED FAILURE WAS NOTED. THE DEVICE WAS MANUFACTURED ACCORDING TO RELEASE SPECIFICATION. THE MANUFACTURER WILL CONTINUE TO MONITOR AND TREND RELATED EVENTS.

    Additional Manufacturer Narrative · 1

    QN#(B)(4). THE DEVICE SAMPLE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR INVESTIGATION AT THE TIME OF THIS REPORT. THE MANUFACTURER WILL CONTINUE TO MONITOR AND TREND RELATED EVENTS.

    Description of Event or Problem · 1

    ALLEGED EVENT: THE RETENTION BALLOON OF 2 SEPARATE CATHETERS BURST WHEN IN USE. THE PROCEDURE HAD BEEN COMPLETED IN BOTH CASES. THE BALLOONS BURST AFTER PATIENTS HAD BEEN RELEASED. PROCEDURE HAD BEEN FOLLOWED USING 10 CC STERILE OF WATER TO FILL THE BALLOONS BUT 1 HAD TO BE REPLACED WITHIN A WEEK AND THE SECOND JUST OVER 2 WEEKS. BOTH WERE REPLACED WITH STANDARD 2-WAY GOLD FOLEY CATHETERS WITHOUT INCIDENT BUT THE DOCTOR FELT THAT THE CATHETER BALLOONS FAILED IN A RELATIVELY SHORT PERIOD. THE PATIENT'S CONDITION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331203 SIMPLASTIC SUPRAPUBIC 16F FOLEY CATHETER KOD TELEFLEX MEDICAL 13GE31

    Patients

    Seq Age Sex Outcome Treatment
    1