BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    13X100 MM 5.0 ML BD VACUTAINER® PLUS PLASTIC SST TUBE. GOLD BD HEMOGARD¿ CLOSURE

    MDR report key: 7073368 · Received November 30, 2017

    Report

    Report Number
    1024879-2017-00776
    Event Type
    Malfunction
    Date Received
    November 30, 2017
    Date of Event
    February 17, 2016
    Report Date
    November 3, 2017
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    JKA
    UDI-DI
    00382903679867
    PMA / PMN Number
    K023075
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    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 #5201706 . 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 A 13X100 MM 5.0 ML BD VACUTAINER® PLUS PLASTIC SST TUBE. GOLD BD HEMOGARD¿ CLOSURE TUBE WAS UNLABELED. THERE WAS NO SERIOUS INJURY OR MEDICAL INTERVENTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    853077 13X100 MM 5.0 ML BD VACUTAINER® PLUS PLASTIC SST TUBE. GOLD BD HEMOGARD¿ CLOSURE BLOOD COLLECTION TUBE JKA BECTON, DICKINSON & CO., (BD) 5201706 00382903679867

    Patients

    Seq Age Sex Outcome Treatment
    1 Other