BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CBC III-(3/16" KIT) PKG/6 WORLD

    MDR report key: 2232411 · Received August 26, 2011

    Report

    Report Number
    2648666-2011-00206
    Event Type
    Injury
    Date Received
    August 26, 2011
    Date of Event
    July 28, 2011
    Report Date
    July 29, 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 WILL NOT BE RETURNED TO THE MANUFACTURER FOR EVALUATION BECAUSE IT WAS DISCARDED BY THE ACCOUNT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE HAD DIFFICULTY SUCTIONING BLOOD DURING USE. ONE HUNDRED FIFTY CC OF BLOOD THAT WAS ALREADY COLLECTED NEEDED TO BE DISCARDED. THE DEVICE WAS REPLACED WITH A BACK-UP DEVICE. THE PATIENT'S OWN PRE-DONATED BLOOD WAS USED FOR REINFUSION. THERE WERE NO ADVERSE CONSEQUENCES RELATED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CBC III-(3/16" KIT) PKG/6 WORLD CAC STRYKER INSTRUMENTS PUERTO RICO 11088012

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other