BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVF 15G X 1 BE 30CM W/CLAMP/WINGEATER

    MDR report key: 2802340 · Received October 24, 2012

    Report

    Report Number
    3002807350-2012-00003
    Event Type
    Injury
    Date Received
    October 24, 2012
    Date of Event
    September 24, 2012
    Report Date
    October 10, 2012
    Manufacturer
    JMS SINGAPORE PTE LTD
    Product Code
    FIE
    PMA / PMN Number
    K111948
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). JMSS (THE MANUFACTURER) IS SUBMITTING THE REPORT ON BEHALF OF (B)(4) (THE IMPORTER). FROM RESERVE SAMPLE EVALUATION AND DEVICE HISTORY RECORD REVIEW, THERE WAS NO ABNORMALITY FOUND AND THE COMPLAINT LOT MET THE QA SPECIFICATIONS PRIOR RELEASING IT TO THE MARKET. THERE WAS NO MALFUNCTION ON THE NEEDLE ITSELF. BASED ON THE INFORMATION PROVIDED BY THE CLINICAL MANAGER, THE NEEDLE DISLODGEMENT OCCURRED AFTER 3HR AND 20MINS INTO HER 4HR DIALYSIS TREATMENT. THE POSSIBILITY EXISTS THAT THE PATIENT MIGHT HAVE MOVED AND THE NEEDLE SET OR BLOOD LINES MIGHT HAVE CAUGHT ON SOMETHING WHICH CAUSED THE NEEDLE SET TO BE DISLODGED FROM THE ACCESS SITE. SOME OF THE OTHER POSSIBLE FACTORS THAT MIGHT RESULT IN THE DISLODGEMENT OF THE NEEDLE SET ARE: POOR QUALITY OF TAPE/POOR ADHESION STRENGTH OF THE TAPE, GRAVITATIONAL PULL ON THE AVF SET, DISINFECTANT/LOTION/MEDICATION USED ON THE PATIENT, PATIENT'S PERSPIRATION, PATIENT'S SKIN CONDITION, AND CANNULATION ANGLE. THUS, NO CORRECTIVE ACTION WILL BE APPLICABLE AS REPORTED INCIDENT IS NOT RELATED TO ANY MALFUNCTION OF JMSS PRODUCT.

    Description of Event or Problem · 1

    FACILITY ((B)(6)) REPORTED: "RECEIVED CALL FROM CAREGIVER STATING PATIENT'S NEEDLE CAME OUT WHILE DIALYZING AND HE CAN'T STOP THE BLEEDING. CAREGIVER CALLED 911 AND CONTINUED HOLDING PRESSURE ON THE SITE, BUT BLEEDING CONTINUED. RN AND TECHNICAL PERSON WENT TO THE PATIENT'S HOUSE AND EMS PRESENT, BLEEDING CEASED, DRESSING INTACT. UNABLE TO DETERMINE BLOOD LOSS RELATED TO TREATMENT AREA CARPETED. PATIENT WAS ALERT, LAST BP 133/72 PER EMS. DOCTOR WAS NOTIFIED, ORDERS RECEIVED TO SEND PATIENT TO ER FOR EVALUATION. PATIENT WAS ABLE TO STAND AND WALK DOWN 3 TO 4 STEPS TO GET ON THE STRETCHER AND WAS TRANSPORTED TO (B)(6) VIA AMBULANCE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AVF 15G X 1 BE 30CM W/CLAMP/WINGEATER FIE FIE JMS SINGAPORE PTE LTD 820-5002-31 110811514

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization