BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO SAMPLING SITE COUPLER

    MDR report key: 570609 · Received January 28, 2005

    Report

    Report Number
    MW1034505
    Event Type
    Malfunction
    Date Received
    January 28, 2005
    Report Date
    January 28, 2005
    Manufacturer
    TERMUO MEDICAL CORP.
    Product Code
    BRZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    TERUMO MEDICAL CORP IS SELLING SAMPLING SITE COUPLERS AS PART OF THEIR TERUFUSION BLOOD COMPONENT TRANSFUSION SETS/MISCELLANEOUS SUPPLIES. UPON RECEIPT AND REVIEW OF THIS ITEM RPTR FOUND THAT THE WRAPPER FOR EACH INDIVIDUAL COUPLER STATED "NOT FOR USE WITH BLOOD OR BLOOD PRODUCTS FOR TRANSFUSION." RPTR CONCERNED BECAUSE THIS SUPPLY IS BEING MARKETED FOR USE WITH BLOOD AND BLOOD PRODUCTS FOR TRANSFUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TERUMO SAMPLING SITE COUPLER * BRZ TERMUO MEDICAL CORP. * 040528P1

    Patients

    Seq Age Sex Outcome Treatment
    1 *