BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    100%SILICONE 2WAY 5CC 16FR

    MDR report key: 4913265 · Received July 14, 2015

    Report

    Report Number
    8040412-2015-00154
    Event Type
    Malfunction
    Date Received
    July 14, 2015
    Date of Event
    June 5, 2015
    Report Date
    June 17, 2015
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    FGH
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE LOT NUMBER WAS NOT PROVIDED; THEREFORE, A DEVICE HISTORY RECORD (DHR) REVIEW COULD NOT BE CONDUCTED. THE RETURNED SAMPLE APPEARED TO BE IN A GOOD CONDITION EXCEPT THAT THE BALLOON WAS SPLIT. CLOSER EXAMINATION ON THE SPLIT BALLOON AREA UNDER DINO-LITE REVEALED SCRATCH MARK NEAR THE TEAR REGION. IN OUR STANDARD OPERATING PROCEDURE 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 ARE SUBJECTED TO LEAK TEST. PRODUCTS THAT PASS THIS TEST WILL BE SUBJECTED TO THE NEXT PROCESS. BASED ON THE INVESTIGATION AND TESTING CONDUCTED ON THE ACTUAL SAMPLE, IT IS BELIEVED THAT THE SCRATCH MARK FOUND NEAR THE SPLIT AREA HAD INITIATED THE TEAR. THEREFORE, WE COULD NOT CONFIRM THIS COMPLAINT AS STATED. NO CONCLUSION CODE AVAILABLE THAT COULD ACCURATELY DESCRIBE THAT THE COMPLAINT WAS CONFIRMED, BUT THE ROOT CAUSE IS UNKNOWN.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE SAMPLE HAS NOT BEEN RETURNED 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: AFTER THE CATHETER WAS INSERTED IN THE SURGERY THEATRE, THE FEMALE PATIENT LOST THE CATHETER A FEW DAYS LATER WHILE WALKING. THE BALLOON SPLIT. THE PATIENT'S CONDITION WAS REPORTED AS FINE.

    Description of Event or Problem · 1

    ALLEGED EVENT: AFTER THE CATHETER WAS INSERTED IN THE SURGERY THEATRE, THE FEMALE PATIENT LOST THE CATHETER A FEW DAYS LATER WHILE WALKING. THE BALLOON SPLIT. THE PATIENT'S CONDITION WAS REPORTED AS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    456582 100%SILICONE 2WAY 5CC 16FR FOLEY CATHETER FGH TELEFLEX MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1