BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN (LH) BLOOD COLLECTION TUBES

    MDR report key: 7560070 · Received June 1, 2018

    Report

    Report Number
    1917413-2018-02266
    Event Type
    Malfunction
    Date Received
    June 1, 2018
    Date of Event
    November 13, 2017
    Report Date
    May 7, 2018
    Manufacturer
    BECTON, DICKINSON & CO.
    Product Code
    JKA
    UDI-DI
    50382903679602
    PMA / PMN Number
    K945952
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    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 #: 7157829, MEDICAL DEVICE EXPIRATION DATE: 06/30/2018, RETURNED TO MANUFACTURER ON: 11/27/2017, DEVICE MANUFACTURE DATE: 06/06/2017, MEDICAL DEVICE LOT #: 7160911, MEDICAL DEVICE EXPIRATION DATE: 06/30/2018, RETURNED TO MANUFACTURER ON: 11/27/2017, DEVICE MANUFACTURE DATE: 06/09/2017. 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 THE BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARIN N (LH) BLOOD COLLECTION TUBES HAD UNDER FILING. NO SERIOUS INJURY MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    402176 BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN (LH) BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION TUBES JKA BECTON, DICKINSON & CO. 7256510 50382903679602

    Patients

    Seq Age Sex Outcome Treatment
    1 Other