BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGEL WING 21G BCS W/LUER ADPTR

    MDR report key: 3944297 · Received May 8, 2014

    Report

    Report Number
    1282497-2014-00036
    Event Type
    Malfunction
    Date Received
    May 8, 2014
    Date of Event
    April 17, 2014
    Report Date
    April 17, 2014
    Manufacturer
    COVIDIEN
    Product Code
    FMI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SUBMIT DATE: (B)(4) 2014. AN INVESTIGATION IS CURRENTLY UNDERWAY, UPON COMPLETION THE RESULTS WILL BE FORWARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON (B)(6) 2014 THAT A CUSTOMER HAD AN ISSUE WITH A BLOOD COLLECTION SET. THE CUSTOMER REPORTS THAT THE NURSE USED THE BUTTERFLY AND ACTIVATED THE SAFETY AND SHE THOUGHT SHE HEARD IT CLICK, BUT WHEN SHE WENT TO THROW IT IN THE SHARPS CONTAINER, SHE WAS STUCK. THE BUTTERFLY NEEDLE WAS AT THE EDGE OF THE SHARPS CONTAINER AND WAS RETRIEVED. UPON INVESTIGATION THE BUTTERFLY, THE METAL END THAT SHOULD HAVE COVERED THE NEEDLE WHEN THE SAFETY WAS ACTIVATED WAS MISSING. STANDARD POST BLOODBORNE PATHOGEN/NEEDLE-STICK EXPOSURE FOLLOW-UP WAS CONDUCTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278099 ANGEL WING 21G BCS W/LUER ADPTR BLOOD COLLECTION SET FMI COVIDIEN 8881225299 2093185

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other