BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SERUM BLOOD COLLECTION TUBE

    MDR report key: 7067721 · Received November 29, 2017

    Report

    Report Number
    1024879-2017-00726
    Event Type
    Malfunction
    Date Received
    November 29, 2017
    Date of Event
    April 18, 2016
    Report Date
    October 30, 2017
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    JKA
    UDI-DI
    00382903678204
    PMA / PMN Number
    K960250
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 # 5211784 . 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 16 X 100 MM X 10 ML BD VACUTAINER® SERUM BLOOD COLLECTION TUBE. THE TUBES WOULD NOT STAY ON TO THE NEEDLE. NO INJURY, OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    845611 BD VACUTAINER® SERUM BLOOD COLLECTION TUBE BLOOD COLLECTION TUBE JKA BECTON, DICKINSON & CO., (BD) 5211784 00382903678204

    Patients

    Seq Age Sex Outcome Treatment
    1 Other