BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® PLUS PLASTIC CITRATE TUBE

    MDR report key: 7081391 · Received December 4, 2017

    Report

    Report Number
    1917413-2017-00404
    Event Type
    Malfunction
    Date Received
    December 4, 2017
    Date of Event
    September 15, 2016
    Report Date
    November 7, 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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: BD RECEIVED SAMPLES FROM THE CUSTOMER FACILITY FOR INVESTIGATION. THE SAMPLES WERE EVALUATED AND THE CUSTOMER'S INDICATED FAILURE MODE FOR OVERFILL WITH THE INCIDENT LOT WAS NOT OBSERVED. ADDITIONALLY, RETENTION SAMPLES WERE EVALUATED, AND THE CUSTOMER'S INDICATED FAILURE MODE FOR OVERFILL WAS CONFIRMED. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT # 6173878. CONCLUSION: NO ROOT CAUSE COULD BE FOUND. ALL CHECKS COMPLY WITH SPECIFICATION REQUIREMENTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE 13 X 75 MM, 2.7 ML BD VACUTAINER® PLUS PLASTIC CITRATE TUBE WAS OVERFILLING. NO INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    859294 BD VACUTAINER® PLUS PLASTIC CITRATE TUBE CITRATE TUBE JKA BECTON, DICKINSON & CO. 6173878 50382903630832

    Patients

    Seq Age Sex Outcome Treatment
    1 Other