BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CBCII BLOOD CONSERVATION KIT W/3/16 INCHROUND PVC WOUND DRAIN

    MDR report key: 2964284 · Received February 15, 2013

    Report

    Report Number
    0001811755-2013-00285
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Date of Event
    January 22, 2013
    Report Date
    January 22, 2013
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    CAC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RECEIVED AT THE MANUFACTURER FOR TESTING. AN EVALUATION WILL BE CONDUCTED UPON RECEIPT OF THE DEVICE, AND A FOLLOW-UP REPORT WILL BE SUBMITTED AFTER THE QUALITY INVESTIGATION IS COMPLETE. (B)(4): DEVICE HAS NOT YET BEEN RECEIVED AT THE MANUFACTURER FOR EVALUATION.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RECEIVED AT THE MANUFACTURER FOR TESTING. AN EVALUATION WILL BE CONDUCTED UPON RECEIPT OF THE DEVICE, AND A FOLLOW-UP REPORT WILL BE SUBMITTED AFTER THE QUALITY INVESTIGATION IS COMPLETE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BLOOD LEAKED FROM THE DEVICE. IT IS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT, ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION. ATTEMPTS CONTINUE TO BE MADE TO OBTAIN THIS INFORMATION FROM THE ACCOUNT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BLOOD LEAKED FROM THE DEVICE. IT IS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT, ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION. ATTEMPTS CONTINUE TO BE MADE TO OBTAIN THIS INFORMATION FROM THE ACCOUNT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69338 CBCII BLOOD CONSERVATION KIT W/3/16 INCHROUND PVC WOUND DRAIN APPARATUS, AUTOTRANSFUSION CAC STRYKER INSTRUMENTS-KALAMAZOO 12074012

    Patients

    Seq Age Sex Outcome Treatment
    1