BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES

    MDR report key: 7592389 · Received June 12, 2018

    Report

    Report Number
    9617032-2018-01747
    Event Type
    Malfunction
    Date Received
    June 12, 2018
    Date of Event
    March 28, 2016
    Report Date
    May 22, 2018
    Manufacturer
    BECTON, DICKINSON AND COMPANY (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 · 1

    MULTIPLE PMA / 510(K) NUMBERS: THERE WERE MULTIPLE PMA / 510(K) NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR THE ADDITIONAL PMA / 510(K) NUMBER IS AS FOLLOWS: PMA / 510(K)#: K023331. BD HAD NOT RECEIVED SAMPLES, BUT PHOTOS WERE PROVIDED BY THE CUSTOMER FACILITY FOR INVESTIGATION. THE PHOTOS WERE EVALUATED AND THE CUSTOMER'S INDICATED FAILURE MODE WITH THE INCIDENT LOT WAS OBSERVED. ADDITIONALLY, RETENTION SAMPLES WERE SELECTED FOR EVALUATION, AND THE CUSTOMER'S INDICATED FAILURE MODE 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® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES WERE TACKY AND HAD GEL ATTACHED TO THE INNER SIDE OF THE TUBE. NO SERIOUS INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    437041 BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) 5089404

    Patients

    Seq Age Sex Outcome Treatment
    1 Other