BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SEDITAINER¿ ERYTHROCYTE SEDIMENTATION RATE (ESR) SYSTEM

    MDR report key: 7058964 · Received November 27, 2017

    Report

    Report Number
    9617032-2017-00225
    Event Type
    Malfunction
    Date Received
    November 27, 2017
    Date of Event
    February 9, 2016
    Report Date
    November 13, 2017
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    PMA / PMN Number
    K953994
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: BD RECEIVED SAMPLES FROM THE CUSTOMER FACILITY FOR INVESTIGATION. THE SAMPLES WERE EVALUATED AND THE CUSTOMER'S INDICATED FAILURE MODE FOR LOW DRAW AND LEAKAGE WITH THE INCIDENT LOT WAS NOT OBSERVED. A REVIEW OF THE MANUFACTURING RECORDS WAS COMPLETED FOR THE INCIDENT LOT #5230473 AND NO ISSUES WERE IDENTIFIED. CONCLUSION: AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BLOOD SPILLED OUT OF GLASS, 10X120 MM, BD VACUTAINER® SPECIALTY TUBES SEDITAINER¿ ERYTHROCYTE SEDIMENTATION RATE (ESR) SYSTEM, 5.0 ML, CONVENTIONAL/BLACK CLOSURE, PAPER LABEL, 1.25 ML SOLUTION 0.105 M BUFFERED SODIUM CITRATE IN THE MOMENT WHEN FILLING BEGAN. NO BLOOD EXPOSURE TO MUCOUS MEMBRANE. NO INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    838816 BD VACUTAINER® SEDITAINER¿ ERYTHROCYTE SEDIMENTATION RATE (ESR) SYSTEM BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) 5230473

    Patients

    Seq Age Sex Outcome Treatment
    1 Other