BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLINIMACS CD34 REAGENT

    MDR report key: 4959955 · Received July 22, 2015

    Report

    Report Number
    3005290010-2015-00006
    Event Type
    Malfunction
    Date Received
    July 22, 2015
    Date of Event
    June 17, 2015
    Report Date
    July 21, 2015
    Manufacturer
    MILTENYI BIOTEC GMBH
    Product Code
    KSR
    PMA / PMN Number
    BH110018
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: THIS COMPLAINT IS CLASSIFIED AS APPLICATION FAILURE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT ONE OF THEIR CLINIMACS CD34 REAGENTS FAILED IN REGARD THAT THE GREY RUBBER STOPPER IN THE VIAL COMPLETELY COLLAPSED IN ON ITSELF WHEN INSERTING THE UNIVERSAL VIAL ADAPTER (MCKESSON, CAT #UR12B20109) IN ORDER TO REMOVE THE REAGENT AND TRANSFER IT TO A BAG. THIS RESULTED IN THE CD34 REAGENT BEING EXPOSED TO THE ENVIRONMENT AND NOT STERILE, RENDERING IT UNACCEPTABLE FOR USE IN THE CELL MANUFACTURING PROCEDURE. THERE WAS A BACKUP VIAL OF THE CLINIMACS CD34 REAGENT IN PLACE WHICH WAS USED TO SUCCESSFULLY COMPLETE THE CELL SEPARATION PROCEDURE. THEREFORE THE PATIENT'S TREATMENT WAS NOT COMPROMISED. BASED ON THE INFORMATION PROVIDED AN ADVERSE EVENT FOR THE PATIENT CAN BE EXCLUDED. THE EVENT HAPPENED AT: (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    477164 CLINIMACS CD34 REAGENT CLINIMACS CD34 REAGENT KSR MILTENYI BIOTEC GMBH NA 6150407007

    Patients

    Seq Age Sex Outcome Treatment
    1