BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JELCO (J & J)

    MDR report key: 54170 · Received December 4, 1996

    Report

    Report Number
    54170
    Event Type
    Injury
    Date Received
    December 4, 1996
    Date of Event
    November 16, 1996
    Report Date
    November 20, 1996
    Manufacturer
    CRITIKON, INC.
    Product Code
    DQO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NJ, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    END HALF OF CATHETER BROKE OFF WHILE HEPARIN LOCK (PRN ADAPTOR) WAS BEING INSERTED. REQUIRED SURGICAL REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JELCO (J & J) Implant IV CATHETER DQO CRITIKON, INC. 1732F *

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention