BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3CC 25X5/8 MAGELLAN SAFETY COMBO

    MDR report key: 3823685 · Received May 1, 2014

    Report

    Report Number
    1017768-2014-00014
    Event Type
    Malfunction
    Date Received
    May 1, 2014
    Date of Event
    April 17, 2014
    Report Date
    April 23, 2014
    Manufacturer
    COVIDIEN
    Product Code
    FMI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 SAFETY NEEDLE. THE CUSTOMER REPORTS THAT SHE WAS USING THE SAFETY SYSTEM APPROPRIATELY AND SOMEHOW THE SAFETY CAP BROKE OFF AT THE TOP AND SHE GOT POKED. SHE WAS USING HER THUMB TO PUSH UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    261976 3CC 25X5/8 MAGELLAN SAFETY COMBO SAFETY NEEDLE FMI COVIDIEN 8881833558 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK