BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SST II PLUS PLASTIC SERUM TUBE

    MDR report key: 7058963 · Received November 27, 2017

    Report

    Report Number
    9617032-2017-00227
    Event Type
    Malfunction
    Date Received
    November 27, 2017
    Date of Event
    April 27, 2016
    Report Date
    November 14, 2017
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    UDI-DI
    00382903679539
    PMA / PMN Number
    K023331
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). RESULTS: 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 FOR BREAKAGE DUE TO CENTRIFUGATION WITH THE INCIDENT LOT WAS NOT OBSERVED. THE PHOTO CONFIRMED THE ITEM WAS BROKEN, BUT IT IS UNCLEAR IF THE DAMAGE WAS DUE TO CENTRIFUGATION. A REVIEW OF THE MANUFACTURING RECORDS WAS COMPLETED FOR THE INCIDENT LOT #6011688 AND NO ISSUES WERE IDENTIFIED. CONCLUSION: WITHOUT A SAMPLE, AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED AS BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE. IT HAS BEEN MENTIONED THAT THIS PARTICULAR CUSTOMER STORED TUBES AT 4-10 DEGREES CELSIUS PRIOR TO CENTRIFUGATION. IT SHOULD BE NOTED THAT THE TUBES CAN BECOME BRITTLE AT LOWER TEMPERATURES AND SHOULD BE ALLOWED TO COME TO ROOM TEMPERATURE PRIOR TO CENTRIFUGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 16 X 100 MM X 8.5 ML BD VACUTAINER® SST II PLUS PLASTIC SERUM TUBE BROKE AFTER REMOVING IT FROM THE CENTRIFUGE. NO INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    838860 BD VACUTAINER® SST II PLUS PLASTIC SERUM TUBE SERUM TUBE JKA BECTON, DICKINSON AND COMPANY (BD) 6011688 00382903679539

    Patients

    Seq Age Sex Outcome Treatment
    1 Other