BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES

    MDR report key: 7432835 · Received April 16, 2018

    Report

    Report Number
    1024879-2018-00464
    Event Type
    Malfunction
    Date Received
    April 16, 2018
    Date of Event
    November 1, 2016
    Report Date
    April 17, 2018
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    JKA
    PMA / PMN Number
    BK050036
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PROBLEM DESCRIPTION WAS CORRECTED TO "IT WAS REPORTED THAT THE BD VACUTAINER SST BLOOD COLLECTION TUBES CONTAINED FM." MEDICAL DEVICE CATALOG # IS CORRECTED TO 367997. MEDICAL DEVICE LOT # IS CORRECTED TO 6092562. MEDICAL DEVICE EXPIRATION DATE IS CORRECTED TO 03/31/2017. DATE RECEIVED BY MANUFACTURER IS CORRECTED TO 11/01/2016. DEVICE MANUFACTURE DATE IS CORRECTED TO 04/01/2016.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD VACUTAINER SST BLOOD COLLECTION TUBES CONTAINED FM.

    Additional Manufacturer Narrative · 1

    BD RECEIVED SAMPLES AND PHOTOS FROM THE CUSTOMER FACILITY FOR INVESTIGATION. THE SAMPLES AND PHOTOS WERE EVALUATED AND THE CUSTOMER¿S INDICATED FAILURE MODE FOR FM INSIDE THE TUBE WITH THE INCIDENT LOT WAS 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 BD RECEIVED SAMPLES FROM THE CUSTOMER FACILITY FOR INVESTIGATION. THE SAMPLES WERE EVALUATED AND THE CUSTOMER'S INDICATED FAILURE MODE FOR FM WITH THE INCIDENT LOT WAS OBSERVED. A REVIEW OF THE MANUFACTURING RECORDS WAS COMPLETED FOR THE INCIDENT LOT AND NO ISSUES WERE IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    277467 BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO., (BD) 6092562

    Patients

    Seq Age Sex Outcome Treatment
    1 Other