BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYPO NEEDLE 25X1 1/2 A BEVEL250E NDL

    MDR report key: 1945297 · Received December 21, 2010

    Report

    Report Number
    1017768-2010-00029
    Event Type
    Malfunction
    Date Received
    December 21, 2010
    Date of Event
    December 14, 2010
    Report Date
    December 14, 2010
    Manufacturer
    COVIDIEN
    Product Code
    FMI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SUBMIT DATE: (B)(4) 2010. 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) 2010 THAT A CUSTOMER HAD AN ISSUE WITH A HYPODERMIC NEEDLE. THE CUSTOMER REPORTS THE NEEDLE DETACHED FROM THE HUB DURING A PROCEDURE. THE SURGEON WAS ABLE TO REMOVE THE NEEDLE FROM THE PT WITH HIS FINGERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HYPO NEEDLE 25X1 1/2 A BEVEL250E NDL HYPODERMIC NEEDLE FMI COVIDIEN 1188825112 A029179

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK