BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JMS

    MDR report key: 2840526 · Received October 5, 2012

    Report

    Report Number
    2840526
    Event Type
    Injury
    Date Received
    October 5, 2012
    Date of Event
    September 24, 2012
    Report Date
    October 5, 2012
    Manufacturer
    JMS SINGAPORE PTE LTD.
    Product Code
    MPB
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    AL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    RECEIVED CALL FROM CAREGIVER STATING PATIENT'S NEEDLE CAME OUT WHILE DIALYZING AND HE CAN'T STOP THE BLEEDING. CAREGIVER CALLED 911 AND CONTINUES 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 ALERT, LAST BP 133/72 PER EMS. DR NOTIFIED, ORDERS RECEIVED TO SEND PATIENT TO MIMC FOR EVALUATION. PATIENT WAS ABLE TO STAND AND WALK DOWN 3 TO 4 STEPS AND GET ON THE STRETCHER AND WAS TRANSPORTED TO MIMC VIA AMBULANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JMS WINGEATER A.V. FISTULA NEEDLE MPB JMS SINGAPORE PTE LTD. 110811514

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization