BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES

    MDR report key: 7477310 · Received May 1, 2018

    Report

    Report Number
    9617032-2018-01217
    Event Type
    Malfunction
    Date Received
    May 1, 2018
    Date of Event
    June 20, 2017
    Report Date
    April 25, 2018
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    UDI-DI
    50382903679558
    PMA / PMN Number
    BK050036
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    "MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 7060835; MEDICAL DEVICE EXPIRATION DATE: 08/31/2018 DEVICE MANUFACTURE DATE: 03/01/2017. MEDICAL DEVICE LOT #: 7086871; MEDICAL DEVICE EXPIRATION DATE: 09/30/2018; DEVICE MANUFACTURE DATE: 03/27/2017. MEDICAL DEVICE LOT #: 7086870; MEDICAL DEVICE EXPIRATION DATE: 09/30/2017; DEVICE MANUFACTURE DATE: 03/27/2017. " (B)(6). BD HAD NOT RECEIVED SAMPLES OR PHOTOS FROM THE CUSTOMER FACILITY FOR EVALUATION; THEREFORE, THE INVESTIGATION WAS LIMITED. 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 LOOSE FITTINGS WHICH LEAKED DURING TRANSPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    317973 BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) 50382903679558

    Patients

    Seq Age Sex Outcome Treatment
    1 Other