BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® PLUS PLASTIC SST TUBE. GOLD BD HEMOGARD¿ CLOSURE

    MDR report key: 7059107 · Received November 27, 2017

    Report

    Report Number
    1024879-2017-00876
    Event Type
    Malfunction
    Date Received
    November 27, 2017
    Date of Event
    July 22, 2016
    Report Date
    October 31, 2017
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    JKA
    UDI-DI
    00382903679836
    PMA / PMN Number
    K023075
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SAMPLE WAS RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT NUMBERS OF 6014582, 6067982, 6092544, AND 6106971. THIRTY TUBES FROM EACH BATCH WERE EVALUATED FOR DRAW WEIGHTS. THERE WERE NO DEFECTS IDENTIFIED. THE TUBES WERE INSPECTED FOR VISUAL DAMAGE WITH NO DEFECTS IDENTIFIED. 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 13X75 MM 3.5 ML BD VACUTAINER® PLUS PLASTIC SST TUBE. GOLD BD HEMOGARD¿ CLOSURE HAD VACUUM ISSUES OR NO VACUUM IN THE TUBE. THE GOLD SSTS HAVE ALSO BEEN NOTICED TO BE LEAKING AT THE NEEDLE IN THE HUB. OUT OF 140 PHLEBOTOMISTS 10 RESPONDED AND 3 OF THOSE REPORTED INSUFFICIENT VACUUM PRESSURE AND THE OTHER 7 DID NOT HAVE ANY REPORTED CONCERNS. THERE WAS NO INJURY OR MEDICAL INTERVENTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    838870 BD VACUTAINER® PLUS PLASTIC SST TUBE. GOLD BD HEMOGARD¿ CLOSURE BLOOD COLLECTION TUBE JKA BECTON, DICKINSON & CO., (BD) 6014582 00382903679836

    Patients

    Seq Age Sex Outcome Treatment
    1 Other