BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER¿ PLASTIC BLOOD COLLECTION TUBES WITH K2EDTA

    MDR report key: 7098884 · Received December 7, 2017

    Report

    Report Number
    9617032-2017-00109
    Event Type
    Malfunction
    Date Received
    December 7, 2017
    Date of Event
    January 8, 2016
    Report Date
    November 20, 2017
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    UDI-DI
    00382903688616
    PMA / PMN Number
    K981013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 # 5250038. CONCLUSION: WITHOUT A 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 DEVICE, BD VACUTAINER¿ PLASTIC BLOOD COLLECTION TUBES WITH K2EDTA, CAME DELIVERED WITHOUT A LABEL. NO MEDICAL INTERVENTION OR INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    876409 BD VACUTAINER¿ PLASTIC BLOOD COLLECTION TUBES WITH K2EDTA VACUTAINER TUBE JKA BECTON, DICKINSON AND COMPANY (BD) 5250038 00382903688616

    Patients

    Seq Age Sex Outcome Treatment
    1 Other