BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® PLUS PLASTIC WHOLE BLOOD TUBE

    MDR report key: 7074419 · Received December 1, 2017

    Report

    Report Number
    1917413-2017-00245
    Event Type
    Malfunction
    Date Received
    December 1, 2017
    Date of Event
    January 27, 2016
    Report Date
    October 31, 2017
    Manufacturer
    BECTON, DICKINSON & CO.
    Product Code
    JKA
    UDI-DI
    00382903678617
    PMA / PMN Number
    K981013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: A SAMPLE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT # 5210790. 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 THE BD VACUTAINER® PLUS PLASTIC WHOLE BLOOD TUBES HAD CRACKS IN THEM. THE CRACKS WERE NOTICED BEFORE USE AND WERE NOT USED. NO SERIOUS INJURY OR MEDICAL INTERVENTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    853606 BD VACUTAINER® PLUS PLASTIC WHOLE BLOOD TUBE BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. 5210790 00382903678617

    Patients

    Seq Age Sex Outcome Treatment
    1 Other