BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DUPLOTIP

    MDR report key: 9244055 · Received October 28, 2019

    Report

    Report Number
    9244055
    Event Type
    Malfunction
    Date Received
    October 28, 2019
    Date of Event
    November 2, 2018
    Report Date
    October 9, 2019
    Manufacturer
    MICROMEDICS, INC.
    Product Code
    FMF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING CASE, BAXTER DUPLOTIP DUAL LUMEN CANNULA REF: 0601138 WAS USED AND SNAPPED IN TWO. PIECE BROKE INSIDE TROCAR AND WAS REMOVED. SURGICAL FIELD SEARCHED FOR FRAGMENTS. ATTENDING SURGEON PRESENT AND AWARE. NO COMPLICATIONS INTRA OP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1040864 DUPLOTIP SYRINGE, PISTON FMF MICROMEDICS, INC. 0601138 173606

    Patients

    Seq Age Sex Outcome Treatment
    1 29565 DA