BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CBCII BLOOD CONSERVATION KIT W/3/16 INCH ROUND PVC

    MDR report key: 2221240 · Received August 16, 2011

    Report

    Report Number
    2648666-2011-00201
    Event Type
    Injury
    Date Received
    August 16, 2011
    Date of Event
    July 26, 2011
    Report Date
    August 1, 2011
    Manufacturer
    STRYKER INSTRUMENTS PUERTO RICO
    Product Code
    CAC
    PMA / PMN Number
    K952224
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS DISCARDED AT THE ACCOUNT. THE DEVICE HISTORY RECORDS, THE NON-CONFORMANCE REPORTS (NCR) DATABASE AND DEVIATION REPORTS WERE REVIEWED FOR THE REPORTED LOT NUMBER FOR INCIDENTS RELATED TO THE ABOVE CONDITION WITHIN A 2 WEEKS PERIOD (+/-) FROM THE LOT MANUFACTURING DATE. NO RELATED NON-CONFORMANCES OR DEVIATION REPORTS WERE FOUND THAT COULD CONTRIBUTE TO THE FAILURE ADDRESSED IN THIS COMPLAINT. NO PROCESS OR DESIGN CHANGES WERE FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER COLLECTING 600 MLS OF BLOOD, THE BLOOD WAS UNABLE TO BE TRANSFERRED TO THE BLOOD BAG. NONE OF THE COLLECTED BLOOD WAS ABLE TO BE RE-INFUSED. THE PATIENT RECEIVED A BLOOD TRANSFUSION FROM A BLOOD BANK AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CBCII BLOOD CONSERVATION KIT W/3/16 INCH ROUND PVC CAC STRYKER INSTRUMENTS PUERTO RICO 11101012

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention