BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FIBRIJECT SINGLE SPRAY APPLICATOR TIP

    MDR report key: 3059477 · Received March 25, 2013

    Report

    Report Number
    2183425-2013-00004
    Event Type
    Malfunction
    Date Received
    March 25, 2013
    Date of Event
    February 21, 2013
    Report Date
    March 21, 2013
    Manufacturer
    MICROMEDICS, INC.
    Product Code
    KYZ
    PMA / PMN Number
    K982372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    TIP CAME LOOSE FROM LUER LOCK AND WENT INTO PT DURING SURGERY. TIP WAS ATTACHED TO A STANDARD SYRINGE. TIP WAS NOTICED DURING POST-OP X-RAY. PRODUCT WAS REMOVED FROM PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    121251 FIBRIJECT SINGLE SPRAY APPLICATOR TIP SYRINGE, IRRIGATING, NON-DENTAL KYZ MICROMEDICS, INC. SA-3671-100 125878

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention BD SYRINGE