BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES

    MDR report key: 7450463 · Received April 23, 2018

    Report

    Report Number
    9617032-2018-00649
    Event Type
    Malfunction
    Date Received
    April 23, 2018
    Date of Event
    December 16, 2016
    Report Date
    April 19, 2018
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    PMA / PMN Number
    BK050036
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MULTIPLE PMA / 510(K) NUMBERS: THERE WERE MULTIPLE PMA / 510(K) NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH PMA / 510 (K) NUMBER IS AS FOLLOWS: K023331 AND BK050036. BD RECEIVED SAMPLES AND PHOTOS FROM THE CUSTOMER FACILITY FOR INVESTIGATION. THE SAMPLES AND PHOTOS WERE EVALUATED AND THE CUSTOMER¿S INDICATED FAILURE MODE FOR FM WITH THE INCIDENT LOT WAS OBSERVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A FRAGMENT OF THE RUBBER STOPPER IN THE BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES HAD BROKEN OFF AND WAS IN THE TUBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292795 BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) 6112703

    Patients

    Seq Age Sex Outcome Treatment
    1 Other