BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3CC LL SYRINGE P-LK O/P

    MDR report key: 6332376 · Received February 15, 2017

    Report

    Report Number
    1017768-2017-00033
    Event Type
    Malfunction
    Date Received
    February 15, 2017
    Report Date
    January 27, 2017
    Manufacturer
    COVIDIEN
    Product Code
    FMI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUBMIT DATE: 02/15/2017. AN INVESTIGATION IS CURRENTLY UNDER WAY; UPON COMPLETION THE RESULTS WILL BE FORWARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON (B)(6) 2017 THAT A CUSTOMER HAD AN ISSUE WITH A SYRINGE. THE CUSTOMER REPORTS THE SYRINGE CRACKED WHEN PERFORMING THE INJECTION. THE PATIENT WAS INVOLVEMENT BUT NO INJURY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114404 3CC LL SYRINGE P-LK O/P SYRINGE FMI COVIDIEN 8881513934 632703

    Patients

    Seq Age Sex Outcome Treatment
    1