BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES

    MDR report key: 7456715 · Received April 24, 2018

    Report

    Report Number
    9617032-2018-00743
    Event Type
    Malfunction
    Date Received
    April 24, 2018
    Date of Event
    April 12, 2017
    Report Date
    April 20, 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

    RETURNED TO MANUFACTURER ON: UNKNOWN. THE INVESTIGATION DATE HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE PMA / 510(K) NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH PMA / 510(K) NUMBER IS LISTED BELOW: PMA / 510(K) #: K023331. 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 84950 WITH THE INCIDENT LOT WAS OBSERVED. ADDITIONALLY, RETENTION SAMPLES WERE SELECTED FOR EVALUATION, AND THE CUSTOMER'S INDICATED FAILURE MODE FOR 84950 WAS NOT OBSERVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES' STOPPERS HAD MOLDING DEFECTS. NO SERIOUS INJURY OR MEDICAL INTERVENTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    298587 BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) 6197969

    Patients

    Seq Age Sex Outcome Treatment
    1 Other