BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VACUETTE SAFETY BLOOD COLLECTION SET WITH LUER

    MDR report key: 2434447 · Received January 26, 2012

    Report

    Report Number
    8020040-2012-00001
    Event Type
    Injury
    Date Received
    January 26, 2012
    Date of Event
    November 25, 2011
    Report Date
    January 26, 2012
    Manufacturer
    GREINER BIO-ONE GMBH
    Product Code
    FMI
    PMA / PMN Number
    K011786
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SBC DEVICE WAS USED AS INFUSION SET FOR 3 DAYS ATTACHED TO PATIENT'S LEFT THIGH SUBCUTANEOUSLY. SBC SET WAS ATTACHED WITH CLEAR PATCH. PATIENT WAS GIVEN MORPHINE VIA A PORT ATTACHED TO THE SBC SET BY THE HOSPITAL. AFTER 3 DAYS OF USE NURSE FOUND SOME BLOOD IN THE TUBING. THEN CHECKED DEVICE BY CAREFULLY REMOVING PATCH AND SAW THAT NEEDLE WAS NOT ATTACHED ANYMORE. X-RAYS LOCATED THE NEEDLE IN PATIENT LEFT THIGH AND HAS MIGRATED TO THE BONE (FEMUR). PATIENT HAD NO SYMPTOMS (E.G. NO PAIN, NO REDNESS, NO FEVER). NEEDLE WAS NOT REMOVED BECAUSE OF PATIENTS CONDITIONS. INITIAL INVESTIGATION SHOWS NO MALFUNCTION OF DEVICE. ACCORDING TO CURRENT INVESTIGATION THE NEEDLE BROKE OFF BY EXTERNAL FORCE DUE TO MOVING OF PATIENT OVER 3 DAYS. ADDITIONALLY DEVICE WAS ATTACHED UNDER BLANKET FOR 3 DAYS AND WAS NOT CLEAR VISIBLE WHEN PATIENT WAS MOVED OR WHEN PATIENT MOVED.

    Description of Event or Problem · 1

    SBC DEVICE WAS USED AS INFUSION SET FOR 3 DAYS ATTACHED TO PATIENT'S LEFT THIGH SUBCUTANEOUSLY. SBC SET WAS ATTACHED WITH CLEAR PATCH. PATIENT WAS GIVEN MORPHINE VIA A PORT ATTACHED TO THE SBC SET BY THE HOSPITAL. AFTER 3 DAYS OF USE NURSE FOUND SOME BLOOD IN THE TUBING. THE CHECKED DEVICE BY CAREFULLY REMOVING PATCH AND SAW THAT NEEDLE WAS NOT ATTACHED ANYMORE. X-RAYS LOCATED THE NEEDLE IN PATIENT LEFT THIGH AND HAS MIGRATED TO THE BONE (FEMUR). PATIENT HAD NO SYMPTOMS (E.G. NO PAIN, NO REDNESS, NO FEVER). NEEDLE WAS NOT REMOVED BECAUSE OF PATIENT'S CONDITIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VACUETTE SAFETY BLOOD COLLECTION SET WITH LUER SBC SET FMI GREINER BIO-ONE GMBH 450099 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1