BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES

    MDR report key: 7443298 · Received April 19, 2018

    Report

    Report Number
    9617032-2018-00496
    Event Type
    Malfunction
    Date Received
    April 19, 2018
    Date of Event
    March 3, 2017
    Report Date
    April 17, 2018
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    PMA / PMN Number
    SEE H.10.
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. THE 510K: K023331 AND BK050036. INVESTIGATION: 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 SMEARED ADDITIVE/ FM 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 THE ADDITIVE INSIDE A BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBE WAS ¿SMEARED¿ AND NOT IN THE RIGHT LOCATION OF THE TUBE. THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    286099 BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) 6179711

    Patients

    Seq Age Sex Outcome Treatment
    1 Other