BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES

    MDR report key: 7582982 · Received June 8, 2018

    Report

    Report Number
    1024879-2018-02100
    Event Type
    Malfunction
    Date Received
    June 8, 2018
    Date of Event
    April 13, 2016
    Report Date
    May 16, 2018
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    JKA
    UDI-DI
    50382903679862
    PMA / PMN Number
    BK050036
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 5205628, MEDICAL DEVICE EXPIRATION DATE: 07/31/2016, DEVICE MANUFACTURE DATE: 07/24/2015. MEDICAL DEVICE LOT #: 5169903, MEDICAL DEVICE EXPIRATION DATE: 06/30/2016, DEVICE MANUFACTURE DATE: 06/18/2015. MEDICAL DEVICE LOT #: 5111799, MEDICAL DEVICE EXPIRATION DATE: 04/30/2016, DEVICE MANUFACTURE DATE: 04/21/2015. (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 BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES HAD ISSUES WITH HEMOLYSIS. NO SERIOUS INJURY OR MEDICAL INTERVENTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    426376 BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO., (BD) 5225757 50382903679862

    Patients

    Seq Age Sex Outcome Treatment
    1 Other