BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACUMED CALLOS INJECT 5CC

    MDR report key: 2814791 · Received November 25, 2009

    Report

    Report Number
    3003890476-2009-00008
    Event Type
    Malfunction
    Date Received
    November 25, 2009
    Date of Event
    January 2, 2009
    Report Date
    November 25, 2009
    Manufacturer
    SKELETAL KINETICS, LLC
    Product Code
    MQV
    PMA / PMN Number
    K051123
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WERE SEVERAL POSSIBILITIES WHICH COULD CAUSE THE SEIZED INJECTION SYRINGE AS DESCRIBED, SUCH AS ROOM TEMPERATURE, THE OCCLUSION OF THE TREATED SITE ETC.

    Description of Event or Problem · 1

    NURSE MIXED AND GAVE SURGEON "CALLOS" TO BE USED IN A COLLES FRACTURE CASE. AFTER THE CANNULA WAS ATTACHED, THE PRODUCT SEIZED UP AND COULDN'T BE INJECTED THROUGH. REMOVED CANNULA AND TRIED AGAIN, HOWEVER, NO CHANGE. A NEW BOX OF INJECT WAS OPENED UP, AS WELL AS A NEW DELIVERY KIT. COOL SALINE WAS RUN THROUGH THE CANNULA TO ENSURE IT WASN'T THE DELIVERY KIT. NEW "CALLOS" WAS MIXED AND SURGEON TRIED AGAIN. GOT SOME "CALLOS" IN, ENOUGH FOR THE PATIENT, BUT IT SEIZED UP AGAIN. THEY TRIED USING A 14 GAUGE PLASTIC ANGIO CATHETER, BUT IT SEIZED UP IN THAT AS WELL. THE SURGEON ALWAYS CHECKS THE INJECTABILITY OF "CALLOS" BEFORE PUTTING IT ON THE CANNULA. THE NURSE MIXED BOTH 5CC INJECT PROPERLY USING THE TIMING CHART AND THE SALES REP TIMED HER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACUMED CALLOS INJECT 5CC 21 CFR 888.3045 MQV MQV SKELETAL KINETICS, LLC 08081312

    Patients

    Seq Age Sex Outcome Treatment
    1