BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® PLUS PLASTIC SST TUBE. GOLD BD HEMOGARD¿

    MDR report key: 7077281 · Received December 1, 2017

    Report

    Report Number
    1024879-2017-00759
    Event Type
    Malfunction
    Date Received
    December 1, 2017
    Date of Event
    September 30, 2015
    Report Date
    November 1, 2017
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    JKA
    UDI-DI
    50382903679862
    PMA / PMN Number
    K901449
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    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 PHOTO WAS SUBMITTED THAT SHOWS THE REPORTED DEFECT. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT # 5050918. 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. MISSING LABEL UNITS CAN BE CAUSED BY THE MALFUNCTION OF THE LABEL APPLICATOR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE 13X100 MM 5.0 ML BD VACUTAINER® PLUS PLASTIC SST TUBE. GOLD BD HEMOGARD¿ DID NOT HAVE A LABEL. NO INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    853288 BD VACUTAINER® PLUS PLASTIC SST TUBE. GOLD BD HEMOGARD¿ BLOOD COLLECTION TUBE JKA BECTON, DICKINSON & CO., (BD) 5050918 50382903679862

    Patients

    Seq Age Sex Outcome Treatment
    1 Other