BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4.5 ML BD VACUTAINER® CITRATETUBE, 13 X 75MM

    MDR report key: 7079569 · Received December 4, 2017

    Report

    Report Number
    9617032-2017-00187
    Event Type
    Malfunction
    Date Received
    December 4, 2017
    Date of Event
    January 26, 2016
    Report Date
    November 2, 2017
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    PMA / PMN Number
    K013971
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER PHONE #: (B)(6). RESULTS: A SAMPLE WAS NOT RETURNED FOR EVALUATION. PHOTOGRAPHS WERE SENT THAT SHOW THE REPORTED DEFECT. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT # 5090310. 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 4.5 ML BD VACUTAINER® CITRATETUBE, 13 X 75MM WAS MISSING A LABEL. NO INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    858362 4.5 ML BD VACUTAINER® CITRATETUBE, 13 X 75MM BLOOD COLLECTION TUBE JKA BECTON, DICKINSON AND COMPANY (BD) 5090310

    Patients

    Seq Age Sex Outcome Treatment
    1 Other