BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CBC II

    MDR report key: 363516 · Received November 30, 2001

    Report

    Report Number
    2648666-2001-00055
    Event Type
    Injury
    Date Received
    November 30, 2001
    Date of Event
    November 5, 2001
    Report Date
    November 6, 2001
    Manufacturer
    STRYKER INSTRUMENTS
    Product Code
    CAC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    PER SUB: IT HAS BEEN REPORTED BY THE HOSP THAT THERE WAS A FAULT WITHIN THE RESEALING MECHANISM OF THE SYSTEM AND PTS INVOLVED HAD TO RECEIVE DONATED BLOOD. PRODUCT WAS DISPOSED OF AT HOSP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54106 CBC II AUTO TRANSFUSION APPARATUS CAC STRYKER INSTRUMENTS 0225-028-000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention