BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 7059151 · Received November 27, 2017

    Report

    Report Number
    1024879-2017-00907
    Event Type
    Malfunction
    Date Received
    November 27, 2017
    Date of Event
    September 5, 2016
    Report Date
    November 1, 2017
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    JKA
    UDI-DI
    50382903679831
    PMA / PMN Number
    K023075
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). RESULTS: A SAMPLE WAS NOT RETURNED FOR EVALUATION. A PHOTO WAS SENT THAT SHOWED THE PERFORATED TOPS. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT # 6092546. 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 24 RUBBER STOPPERS OF THE BD VACUTAINER® PLUS PLASTIC SST TUBE. GOLD BD HEMOGARD¿ CLOSURE WERE DISCOVERED TO BE PERFORATED DURING AN INSPECTION. NO INJURY OR MEDICAL INTERVENTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    838886 BD VACUTAINER® PLUS PLASTIC SST TUBE. GOLD BD HEMOGARD¿ CLOSURE BLOOD COLLECTION TUBE JKA BECTON, DICKINSON & CO., (BD) 6092546 50382903679831

    Patients

    Seq Age Sex Outcome Treatment
    1 Other