BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLOOD GAS BLOOD COLLECTION CAPILLARY TUBE

    MDR report key: 517969 · Received March 25, 2004

    Report

    Report Number
    1217157-2004-00004
    Event Type
    Injury
    Date Received
    March 25, 2004
    Date of Event
    March 15, 2004
    Report Date
    March 25, 2004
    Manufacturer
    BAYER CORP.
    Product Code
    GIO
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    BLOOD GAS CAPILLARY TUBE SHATTERED UPON INTRODUCTION TO THE RAPIDLAB 865 BLOOD GAS ANALYZER. SPECIMEN WAS FROM A PT WITH KNOWN HEP C. OPERATOR HAS BEEN TREATED PER HOSP PROTOCOL. IT WAS NOTED LATER THAT THE OPERATOR WAS NOT USING THE RECOMMENDED CAPILLARY TUBE AND THEY MAY HAVE BEEN PLACING ADDITIONAL STRESS ON THE DEVICE WITH THEIR TECHNIQUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BLOOD GAS BLOOD COLLECTION CAPILLARY TUBE LITHIUM HEPARINIZED CAPILLARY TUBES GIO BAYER CORP. NA 0707227

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other