BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRANSURETHRAL CATHETER

    MDR report key: 4929132 · Received July 21, 2015

    Report

    Report Number
    8040412-2015-00155
    Event Type
    Malfunction
    Date Received
    July 21, 2015
    Date of Event
    June 12, 2015
    Report Date
    June 23, 2015
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    FGH
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HISTORY RECORD FOR LOT (13DT29) WAS REVIEWED AND NO ISSUE THAT COULD HAVE CONTRIBUTED TO THE REPORTED FAILURE WAS NOTED. THE DEVICE WAS MANUFACTURED ACCORDING TO RELEASE SPECIFICATION. NO ALLEGED DEFECTIVE PRODUCT OR REPRESENTATIVE SAMPLE WAS RETURNED FOR INVESTIGATION PURPOSES. THE CATHETER LEAK COULD BE DUE TO VARIOUS REASONS. HOWEVER, IN THE ABSENCE OF THE COMPLAINT SAMPLE, FURTHER INVESTIGATION COULD NOT BE CONDUCTED AND THE ACTUAL ROOT CAUSE OF THIS PHENOMENON COULD NOT BE DETERMINED. THEREFORE, THIS COMPLAINT COULD NOT BE CONFIRMED.

    Additional Manufacturer Narrative · 1

    (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 HEAD NURSE FROM THE REHABILITATION UNIT REPORTED THAT THE CATHETER WAS LEAKING. THE MEASURE TAKEN BY THE NURSE WAS TO REINFLATE THE CATHETER WITH 8 CC. THE PATIENT'S CONDITION WAS REPORTED AS UNKNOWN.

    Description of Event or Problem · 1

    ALLEGED EVENT: THE HEAD NURSE FROM THE REHABILITATION UNIT REPORTED THAT THE CATHETER WAS LEAKING. THE MEASURE TAKEN BY THE NURSE WAS TO REINFLATE THE CATHETER WITH 8 CC.THE PATIENT'S CONDITION WAS REPORTED AS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    472521 TRANSURETHRAL CATHETER FOLEY CATHETER FGH TELEFLEX MEDICAL 13DT29

    Patients

    Seq Age Sex Outcome Treatment
    1