BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES

    MDR report key: 7520094 · Received May 16, 2018

    Report

    Report Number
    9617032-2018-02245
    Event Type
    Malfunction
    Date Received
    May 16, 2018
    Date of Event
    September 11, 2017
    Report Date
    May 3, 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
    PO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR OTHER LOT NUMBERS IS AS FOLLOWS: MEDICAL DEVICE LOT #: 6243647, MEDICAL DEVICE EXPIRATION DATE: 02/28/2018, DEVICE MANUFACTURE DATE: 08/30/2016, MEDICAL DEVICE LOT #: 6228769, MEDICAL DEVICE EXPIRATION DATE: 02/28/2018, DEVICE MANUFACTURE DATE: 08/15/2016, MEDICAL DEVICE LOT #: 7100876, MEDICAL DEVICE EXPIRATION DATE: 09/30/2018, DEVICE MANUFACTURE DATE: 04/10/2017, MEDICAL DEVICE LOT #: 7130945, MEDICAL DEVICE EXPIRATION DATE: 11/30/2018, DEVICE MANUFACTURE DATE: 05/10/2017, MEDICAL DEVICE LOT #: 6277666, MEDICAL DEVICE EXPIRATION DATE: 03/31/2018, DEVICE MANUFACTURE DATE: 10/03/2016. (B)(6). 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 THAT BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES WERE UNDERFILLING. NO REPORT OF SERIOUS INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    359842 BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) 7020979

    Patients

    Seq Age Sex Outcome Treatment
    1 Other