BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SST¿ TUBE 13X75MM, 3.5 ML

    MDR report key: 7058992 · Received November 27, 2017

    Report

    Report Number
    1024879-2017-00804
    Event Type
    Malfunction
    Date Received
    November 27, 2017
    Date of Event
    August 16, 2016
    Report Date
    October 27, 2017
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    JKA
    UDI-DI
    00382903679867
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: A SAMPLE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT #6120706. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD VACUTAINER® SST¿ TUBE 13X75MM, 3.5 ML HAD ITS CAP COME OFF A GOLD TUBE IN A CENTRIFUGE. THE CENTRIFUGE HAD JUST STARTED WHEN THE PHLEBOTOMIST HEARD A POP. THERE WAS NO BLOOD EXPOSURE. NO INJURY OR MEDICAL INTERVENTION WAS NECESSARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    840867 BD VACUTAINER® SST¿ TUBE 13X75MM, 3.5 ML BLOOD COLLECTION TUBES JKA BECTON, DICKINSON & CO., (BD) 6120706 00382903679867

    Patients

    Seq Age Sex Outcome Treatment
    1 Other