BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES

    MDR report key: 7469748 · Received April 27, 2018

    Report

    Report Number
    9617032-2018-00773
    Event Type
    Malfunction
    Date Received
    April 27, 2018
    Date of Event
    January 5, 2017
    Report Date
    April 23, 2018
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    PMA / PMN Number
    K023331
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE THE DEVICE WAS RETURNED TO MANUFACTURER IS UNKNOWN. INVESTIGATION DATE USED FOR THIS FIELD. MULTIPLE PMA/510(K)#S: K023331 AND BK050036. 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 74560 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

    I WAS REPORTED THAT A BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBE HAD BLACK FOREIGN MATTER IN THE GEL. NO REPORT OF SERIOUS INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313551 BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) 6112703

    Patients

    Seq Age Sex Outcome Treatment
    1 Other