BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    13 X 75 MM, 2.7 ML BD VACUTAINER® PLUS PLASTIC CITRATE TUBE

    MDR report key: 7058790 · Received November 27, 2017

    Report

    Report Number
    1917413-2017-00171
    Event Type
    Malfunction
    Date Received
    November 27, 2017
    Date of Event
    March 25, 2016
    Report Date
    November 1, 2017
    Manufacturer
    BECTON, DICKINSON & CO.
    Product Code
    JKA
    UDI-DI
    50382903630832
    PMA / PMN Number
    K013971
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: REPRESENTATIVE SAMPLES WERE RECEIVED FROM CUSTOMER, APPROXIMATELY 100 SAMPLES FROM SAME LOT# 5251639. TWENTY REPRESENTATIVE TUBES WERE DRAW TESTED AND MEASURED. ALL SAMPLE TUBES PRODUCED RESULTS WELL WITHIN SPECIFICATION LIMITS AND NO STOPPER PULL OUT WAS NOTICED. NO DEFECTS ON RETURNED REPRESENTATIVE SAMPLES WERE IDENTIFIED AND COULD NOT DUPLICATE OR CONFIRM CUSTOMERS' INDICATED FAILURE MODE. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT # 5251639. CONCLUSION: UNCONFIRMED. WITHOUT ACTUAL SAMPLE, AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED AS BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMERS¿ INDICATED FAILURE MODE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE STOPPER CAP POPPED OFF FROM A 13 X 75 MM, 2.7 ML BD VACUTAINER® PLUS PLASTIC CITRATE TUBE, AFTER FINISHING THE PATIENT BLOOD DRAW. NO SERIOUS INJURY, BLOOD TO MUCOUS MEMBRANE EXPOSURE OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    841127 13 X 75 MM, 2.7 ML BD VACUTAINER® PLUS PLASTIC CITRATE TUBE CITRATE SERUM TUBES JKA BECTON, DICKINSON & CO. 5251639 50382903630832

    Patients

    Seq Age Sex Outcome Treatment
    1 Other