BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DOME SUBCUTANEOUS PORT W/GROSHING CATHETER

    MDR report key: 2759 · Received September 16, 1992

    Report

    Report Number
    2759
    Event Type
    Malfunction
    Date Received
    September 16, 1992
    Date of Event
    March 26, 1992
    Report Date
    April 8, 1992
    Manufacturer
    DAVOL, INC.
    Product Code
    MDX
    Product Problem
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    THE PATIENT HAD A GROSHONG PORT PLACED FOR CHEMOTHERAPY ON FEBRUARY 22, 1992. AT SURGERY ON 3/26/92 IT WAS FOUND THAT THE CATHETER EMBEDDED INTO THE RIGHT ATRIUM OF THE HEART SECONDARY TO TRANSECTION OF THE CATHETER AT THE PORT HUB. THE CATHETER WAS RETREIVED VIA TRANS JUGULAR ROUTEINVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. PATIENT MEDICAL STATUS PRIOR TO EVENT: FAIR CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY. NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, VISUAL EXAMINATION. RESULTS OF EVALUATION: COMPONENT FAILURE. CONCLUSION: DEVICE FAILURE OCCURRED AND WAS RELATED TO EVENT, OTHER. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: DEVICE PERMANENTLY REMOVED FROM SERVICE, OTHER. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DOME SUBCUTANEOUS PORT W/GROSHING CATHETER Implant PORT-A-CATH MDX DAVOL, INC. 60285 36LB2018

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other