BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES

    MDR report key: 7500796 · Received May 9, 2018

    Report

    Report Number
    9617032-2018-02157
    Event Type
    Malfunction
    Date Received
    May 9, 2018
    Date of Event
    October 23, 2017
    Report Date
    May 8, 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
    EI
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    "MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR THE ADDITIONAL LOT NUMBERS IS AS FOLLOWS: MEDICAL DEVICE LOT #: 7178843, MEDICAL DEVICE EXPIRATION DATE: 12/31/2018, DEVICE MANUFACTURE DATE: 06/27/2017. MEDICAL DEVICE LOT #: 7163550, MEDICAL DEVICE EXPIRATION DATE: 11/30/2018, DEVICE MANUFACTURE DATE: 06/12/2017. MEDICAL DEVICE LOT #: 7060845, MEDICAL DEVICE EXPIRATION DATE: 08/31/2018, DEVICE MANUFACTURE DATE: 03/01/2017. ". DATE DEVICE RETURNED TO MANUFACTURER IS UNKNOWN. THE DATE OF INVESTIGATION WAS USED. (B)(6). BD RECEIVED SAMPLES AND PHOTOS FROM THE CUSTOMER FACILITY FOR INVESTIGATION. THE SAMPLES WERE EVALUATED AND THE CUSTOMER'S INDICATED FAILURE MODE WITH THE INCIDENT LOT WAS NOT OBSERVED. THE PHOTOS WERE EVALUATED AND THE CUSTOMER'S INDICATED FAILURE MODE WITH THE INCIDENT LOT WAS OBSERVED. ADDITIONALLY, RETENTION SAMPLES WERE SELECTED FOR EVALUATION, AND THE CUSTOMER'S INDICATED FAILURE MODE 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 THAT THE BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES HAD GEL GLOBULES IN THE SERUM, RED CELLS AND FIBRIN AT THE TOP OF THE TUBE, AND GEL SMEARING ON THE SIDE OF THE TUBES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342819 BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) 7100881

    Patients

    Seq Age Sex Outcome Treatment
    1 Other