BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CBC II-(1/8" KIT) PKG/6 WORLD

    MDR report key: 2070984 · Received April 19, 2011

    Report

    Report Number
    2648666-2011-00111
    Event Type
    Injury
    Date Received
    April 19, 2011
    Date of Event
    March 14, 2011
    Report Date
    March 23, 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
    JA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS DISCARDED AT THE ACCOUNT. THE DEVICE HISTORY RECORD WAS REVIEWED 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 THE LUER CONNECTOR DISCONNECTED DURING USE. NONE OF THE COLLECTED BLOOD WAS ABLE TO BE RE-INFUSED TO THE PATIENT. ALTHOUGH THE ACCOUNT HAD A BACK UP ON HAND, THIS DEVICE WAS USED AS A DRAIN AND THE PATIENT RECEIVED A BLOOD TRANSFUSION FROM PRE-DONATED BLOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CBC II-(1/8" KIT) PKG/6 WORLD CAC STRYKER INSTRUMENTS PUERTO RICO 10195012

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention