BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES

    MDR report key: 7527601 · Received May 18, 2018

    Report

    Report Number
    1024879-2018-02392
    Event Type
    Malfunction
    Date Received
    May 18, 2018
    Date of Event
    June 16, 2017
    Report Date
    April 27, 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
    IL, 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 #: 6329539, MEDICAL DEVICE EXPIRATION DATE: 11/30/2017. RETURNED TO MANUFACTURER ON: NOT RETURNED, DEVICE MANUFACTURE DATE: 11/24/2016. MEDICAL DEVICE LOT #: 7074711, MEDICAL DEVICE EXPIRATION DATE: 03/31/2018, RETURNED TO MANUFACTURER ON: NOT RETURNED, DEVICE MANUFACTURE DATE: 03/15/2017. MEDICAL DEVICE LOT #: 7074711, MEDICAL DEVICE EXPIRATION DATE: 03/31/2018, RETURNED TO MANUFACTURER ON: NOT RETURNED, DEVICE MANUFACTURE DATE: 03/15/2017. MEDICAL DEVICE LOT #: 7041762, MEDICAL DEVICE EXPIRATION DATE: 01/31/2018, RETURNED TO MANUFACTURER ON: 06/29/2017, DEVICE MANUFACTURE DATE: 02/10/2017. MEDICAL DEVICE LOT #: 7058895, MEDICAL DEVICE EXPIRATION DATE: 02/28/2018, RETURNED TO MANUFACTURER ON: NOT RETURNED, DEVICE MANUFACTURE DATE: 02/27/2017. ". BD RECEIVED SAMPLES AND PHOTOS FROM THE CUSTOMER FACILITY FOR INVESTIGATION. THE SAMPLES AND PHOTOS WERE EVALUATED AND THE CUSTOMER¿S INDICATED FAILURE MODE WITH THE INCIDENT LOT WAS NOT OBSERVED. ADDITIONALLY, 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¿ BLOOD COLLECTION TUBES HAD GEL MIGRATION FAILED. NO SERIOUS INJURY MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    367793 BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO., (BD) 6354674 50382903679862

    Patients

    Seq Age Sex Outcome Treatment
    1 Other