BEUDAMED
    FDA Adverse Event Other Summary report: N

    16 GAUGE X 2 1/4" CATHLON

    MDR report key: 216220 · Received March 24, 1999

    Report

    Report Number
    216220
    Event Type
    Other
    Date Received
    March 24, 1999
    Date of Event
    February 21, 1999
    Report Date
    March 23, 1999
    Manufacturer
    CRITIKON, INC. J & J DIVISION
    Product Code
    FOZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PATIENT HAD #16 JELCO STARTED IN SURGERY. IT WAS LOCATED IN ANTICUBITAL AREA. WHEN NURSE IN TELEMETRY WAS ATTEMPTING TO REMOVE JELCO, NO RESISTANCE WAS MET, BUT THE BOTTOM PART OF THE LUMEN REMAINED UNDER THE PATIENT'S SKIN & LOOKED AS THOUGH IT HAD BEEN PINCHED IN HALF. PHYSICIAN WAS IMMEDIATELY NOTIFIED & CAME TO REMOVE THE REMAINING PIECES WHICH REQUIRED 2 OR 3 CUTS TO RETRIEVE THE ENTIRE JELCO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 16 GAUGE X 2 1/4" CATHLON 16 GAUGE X 2 1/4" CATHLON IV PLACEMENT FOZ CRITIKON, INC. J & J DIVISION * *

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other