BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    100%SILICONE 2WAY 5CC 16FR

    MDR report key: 5150265 · Received October 14, 2015

    Report

    Report Number
    8040412-2015-00201
    Event Type
    Malfunction
    Date Received
    October 14, 2015
    Date of Event
    September 3, 2015
    Report Date
    September 15, 2015
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    KOD
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE LOT WAS NOT PROVIDED; THEREFORE; A DHR REVIEW COULD NOT BE CONDUCTED. ONE ACTUAL SAMPLE WAS RETURNED FOR INVESTIGATION. INVESTIGATION WAS CONDUCTED BY INFLATING THE RETURNED SAMPLE WITH 10ML OF RED COLOR WATER AND LEFT ON THE WORKBENCH FOR 20 MINUTES. THE BALLOON WAS ABLE TO STAY INFLATED WITHOUT ANY ISSUES. IN OUR STANDARD OPERATING PROCEDURES THE RAW BALLOONS ARE SUBJECTED TO 100% VISUAL INSPECTION. DEFECTIVE RAW BALLOON WILL BE CULLED OUT BEFORE SENT TO THE NEXT PROCESS. ALL FOLEY CATHETERS WERE THEN SUBJECTED TO LEAK TEST. THERE WAS NO FAULT FOUND AND NO LEAK WAS FOUND AT THE BALLOON AREA OF THE RETURNED SAMPLE. BASED ON THE INVESTIGATION, DEFECT OF LEAK BALLOON COULD NOT BE FOUND IN THE RETURNED SAMPLE. THEREFORE, THIS COMPLAINT COULD NOT BE CONFIRMED.

    Description of Event or Problem · 1

    ALLEGED EVENT: AFTER INSERTING THE CATHETER, AN ATTEMPT WAS MADE TO FILL THE BALLOON AND DURING THE INFLATION PROCESS THE CATHETER CAME OUT AND THE BALLOON HAD BURST. THE PATIENT'S CONDITION WAS REPORTED AS FINE.

    Description of Event or Problem · 1

    ALLEGED EVENT: AFTER INSERTING THE CATHETER, AN ATTEMPT WAS MADE TO FILL THE BALLOON AND DURING THE INFLATION PROCESS THE CATHETER CAME OUT AND THE BALLOON HAD BURST. THE PATIENT'S CONDITION WAS REPORTED AS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    680548 100%SILICONE 2WAY 5CC 16FR KOD TELEFLEX MEDICAL UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1