BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES

    MDR report key: 7472431 · Received April 30, 2018

    Report

    Report Number
    1024879-2018-02372
    Event Type
    Malfunction
    Date Received
    April 30, 2018
    Date of Event
    April 13, 2017
    Report Date
    April 24, 2018
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    JKA
    UDI-DI
    50382903679831
    PMA / PMN Number
    BK050036
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. "MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 6281852, EXPIRATION DATE: 2017-09-30, MANUFACTURE DATE: 2016-10-07. MEDICAL DEVICE LOT #: 6281853, EXPIRATION DATE: 2017-09-30, MANUFACTURE DATE: 2016-10-07. MEDICAL DEVICE LOT #: 6295673, EXPIRATION DATE: 2017-10-31, MANUFACTURE DATE: 2016-10-21. MEDICAL DEVICE LOT #: 6307946, EXPIRATION DATE: 2017-10-31, MANUFACTURE DATE: 2016-11-02. MEDICAL DEVICE LOT #: 6328895, EXPIRATION DATE: 2017-11-30, MANUFACTURE DATE: 2016-11-23. BD RECEIVED SAMPLES FROM THE CUSTOMER FACILITY FOR INVESTIGATION. THE SAMPLES WERE EVALUATED AND THE CUSTOMER'S INDICATED FAILURE MODE FOR (B)(6) 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¿ BLOOD COLLECTION TUBES HAD RED CELL HANG UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    317427 BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO., (BD) 6263614 50382903679831

    Patients

    Seq Age Sex Outcome Treatment
    1 Other