BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® TUBES K2EDTA 5.4MG PLUS

    MDR report key: 7077304 · Received December 1, 2017

    Report

    Report Number
    9617032-2017-00258
    Event Type
    Malfunction
    Date Received
    December 1, 2017
    Date of Event
    April 20, 2016
    Report Date
    November 2, 2017
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    PMA / PMN Number
    K981013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). RESULTS: A REPRESENTATIVE SAMPLE WAS RETURNED FOR EVALUATION. THE SAMPLE WAS TESTED FOR STOPPER PULL OUT AND THE RESULTS DID NOT CONFIRM THE COMPLAINT. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT # 5173255. CONCLUSION: WITHOUT THE ACTUAL 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 THE BD VACUTAINER® TUBES K2EDTA 5.4MG PLUS 3 ML 13 X 75 MM STOPPER WAS PULLING OUT WHICH COULD LEAD TO LEAKAGE. NO INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    853302 BD VACUTAINER® TUBES K2EDTA 5.4MG PLUS BLOOD COLLECTION TUBE JKA BECTON, DICKINSON AND COMPANY (BD) 5173255

    Patients

    Seq Age Sex Outcome Treatment
    1 Other