BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    100% SIL TIEMANN 2WAY 5CC

    MDR report key: 5012245 · Received August 18, 2015

    Report

    Report Number
    8040412-2015-00175
    Event Type
    Malfunction
    Date Received
    August 18, 2015
    Date of Event
    July 18, 2015
    Report Date
    July 23, 2015
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    FGH
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL METHOD: DEVICE HISTORY RECORD FOR LOT (14FE26) WAS REVIEWED AND NO ISSUE THAT COULD HAVE CONTRIBUTED TO THE REPORTED FAILURE WAS NOTED. THE DEVICE WAS MANUFACTURED ACCORDING TO RELEASE SPECIFICATION. ONE ACTUAL SAMPLE WAS RETURNED FOR INVESTIGATION. BASED ON OBSERVATION THE BALLOON OF THE SAMPLE WAS SPLIT. A SIMULATION TEST WAS CONDUCTED WITH REPRESENTATIVE SAMPLES FROM PRODUCTION ON THE SAME CATHETER SIZE AND BALLOON VOLUME. NO DEFLATION ISSUE WAS OBSERVED. BALLOONS ARE STILL INFLATED TO ITS NORMAL CONDITION AND SHAPE. IN OUR CURRENT STANDARD OPERATING PROCEDURE, THE PRODUCTS ARE SUBJECTED TO 100% VISUAL INSPECTION, AND LEAK TEST. ANY DEFECTIVE RAW BALLOON WILL BE CULLED OUT BEFORE BEING SENT TO THE NEXT PROCESS. BASED ON THE INVESTIGATION CONDUCTED, WE COULD NOT LINK ANY PROCESS DISCREPANCY THAT COULD LEAD TO THE BALLOON SPLIT ISSUE. THEREFORE, WE COULD NOT CONFIRM THE COMPLAINT, AS STATED.

    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 PATIENT LOST THE CATHETER WHILE BEING TRANSFERRED TO THE TOILET. THERE WERE NO CLINICAL CONSEQUENCES AS A RESULT OF THE INCIDENT. THE CATHETER HAD BEEN IN PLACE FOR NINE DAYS PRIOR TO THE INCIDENT. THE PATIENT'S CONDITION WAS REPORTED AS FINE.

    Description of Event or Problem · 1

    ALLEGED EVENT: THE PATIENT LOST THE CATHETER WHILE BEING TRANSFERRED TO THE TOILET. THERE WERE NO CLINICAL CONSEQUENCES AS A RESULT OF THE INCIDENT. THE CATHETER HAD BEEN IN PLACE FOR NINE DAYS PRIOR TO THE INCIDENT. THE PATIENT'S CONDITION WAS REPORTED AS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    545182 100% SIL TIEMANN 2WAY 5CC FGH TELEFLEX MEDICAL 14FE26

    Patients

    Seq Age Sex Outcome Treatment
    1