BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CBCII BLOOD CONSERVATION RESERVOIR ONLY

    MDR report key: 2801467 · Received October 11, 2012

    Report

    Report Number
    2648666-2012-00331
    Event Type
    Injury
    Date Received
    October 11, 2012
    Date of Event
    September 6, 2012
    Report Date
    September 14, 2012
    Manufacturer
    STRYKER INSTRUMENTS PUERTO RICO
    Product Code
    CAC
    PMA / PMN Number
    K970714
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WILL NOT BE RETURNED TO THE MFR FOR EVAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE LEAKED. THE TUBE OF THE POUCH WAS FOUND TO BE WELDED ON THE OUTSIDE OF THE BAG. IT IS UNK HOW MUCH BLOOD WAS LOST. AN UNK AMOUNT OF BAGGED BLOOD WAS REQUIRED FOR THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CBCII BLOOD CONSERVATION RESERVOIR ONLY CAC STRYKER INSTRUMENTS PUERTO RICO UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other| R