BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® LITHIUM HEPARINN 75 USP UNITS BLOOD COLLECTION TUBES

    MDR report key: 7584608 · Received June 8, 2018

    Report

    Report Number
    1917413-2018-01836
    Event Type
    Malfunction
    Date Received
    June 8, 2018
    Date of Event
    May 9, 2016
    Report Date
    May 13, 2019
    Manufacturer
    BECTON, DICKINSON & CO.
    Product Code
    JKA
    UDI-DI
    50382903678841
    PMA / PMN Number
    K945952
    Removal / Correction Number
    PAS-18-1175-FA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: BD IS ISSUING A VOLUNTARY MEDICAL DEVICE CORRECTION FOR BD VACUTAINER® PLASTIC LITHIUM HEPARIN TUBES. FALSE ELEVATION OF CARBOXYHEMOGLOBIN (COHB) RESULTS HAVE BEEN REPORTED WHEN ANALYZING VENOUS BLOOD SAMPLES COLLECTED WITH BD VACUTAINER® PLASTIC LITHIUM HEPARIN TUBES WITH THE IL GEM 4000 INSTRUMENT. PLEASE REFERENCE BD RECALL #: PAS-18-1175-FA.

    Description of Event or Problem · 0

    IT WAS REPORTED THE BD VACUTAINER® LITHIUM HEPARINN 75 USP UNITS BLOOD COLLECTION TUBES WERE HAVING ERRONEOUS RESULT , NO REPORT OF MEDICAL INTERVENTIONS OR SERIOUS INJURY.

    Additional Manufacturer Narrative · 1

    RESULT: BD RECEIVED SAMPLES FROM THE CUSTOMER FACILITY FOR INVESTIGATION. THE SAMPLES WERE EVALUATED AND THE CUSTOMER'S INDICATED FAILURE MODE WITH THE INCIDENT LOT WAS NOT OBSERVED. A REVIEW OF THE MANUFACTURING RECORDS WAS COMPLETED FOR THE INCIDENT LOT AND NO ISSUES WERE IDENTIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE BD VACUTAINER® LITHIUM HEPARINN 75 USP UNITS BLOOD COLLECTION TUBES WERE HAVING ERRONEOUS RESULT , NO REPORT OF MEDICAL INTERVENTIONS OR SERIOUS INJURY

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    426913 BD VACUTAINER® LITHIUM HEPARINN 75 USP UNITS BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. 5272697 50382903678841

    Patients

    Seq Age Sex Outcome Treatment
    1 Other