BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN CATHETER

    MDR report key: 5968141 · Received September 21, 2016

    Report

    Report Number
    2021898-2016-00344
    Event Type
    Malfunction
    Date Received
    September 21, 2016
    Date of Event
    July 30, 2016
    Report Date
    August 22, 2016
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS UNAVAILABLE FOR RETURN. THEREFORE AN EVALUATION OF THE DEVICE PERFORMANCE WAS NOT POSSIBLE. THE INSTRUCTIONS FOR USE THAT ACCOMPANY THE DEVICE CAUTIONS THAT LOW TEAR STRENGTH IS A CHARACTERISTIC OF MOST UNREINFORCED SILICONE ELASTOMER MATERIALS, AND THAT CARE MUST BE TAKEN WITH THE HANDLING AND PLACEMENT OF THE SILICONE ELASTOMER CATHETER TUBING TO AVOID CUTS, NICKS, OR TEARS. A REVIEW OF THE MANUFACTURING RECORDS WAS NOT POSSIBLE AS NO LOT NUMBER WAS PROVIDED. ALL CATHETERS ARE 100% INSPECTED AT THE TIME OF MANUFACTURE. ADDITIONAL PATIENT/DEVICE INFORMATION: IT WAS LATER REPORTED THAT THIS EVENT WAS INVOLVING THE EVD CATHETER, CATALOG AND LOT NUMBERS UNKNOWN. IT WAS REPORTED THAT THERE WAS NO ALLEGATION THAT THE BECKER II EDMS HAD MALFUNCTIONED OR WAS NOT WORKING PROPERLY. ACCORDING TO THE REPORT, THE EVD CATHETER WAS REPLACED WITH ANOTHER CATHETER. THE REPORT STATED THAT THE DEVICE HAD BEEN DISCARDED AT THE FACILITY. REPORTEDLY, THERE WAS NO INJURY TO THE PATIENT AND THE PATIENT HAS BEEN DISCHARGED.

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS UNAVAILABLE FOR RETURN. THEREFORE AN EVALUATION OF THE DEVICE PERFORMANCE WAS NOT POSSIBLE. THE INSTRUCTIONS FOR USE THAT ACCOMPANY THE DEVICE CAUTIONS THAT LOW TEAR STRENGTH IS A CHARACTERISTIC OF MOST UNREINFORCED SILICONE ELASTOMER MATERIALS, AND THAT CARE MUST BE TAKEN WITH THE HANDLING AND PLACEMENT OF THE SILICONE ELASTOMER CATHETER TUBING TO AVOID CUTS, NICKS, OR TEARS. IT ALSO CAUTIONS THAT TO AVOID POSSIBLE TRANSECTION OF THE CATHETER DURING CATHETER PLACEMENT, THE CATHETER SHOULD NEVER BE WITHDRAWN THROUGH THE TUOHY NEEDLE. IF THE CATHETER NEEDS TO BE WITHDRAWN, THE TUOHY NEEDLE, GUIDEWIRE, AND THE CATHETER MUST BE REMOVED SIMULTANEOUSLY. A REVIEW OF THE MANUFACTURING RECORDS WAS NOT POSSIBLE AS NO LOT NUMBER WAS PROVIDED. ALL CATHETERS ARE 100% INSPECTED AT THE TIME OF MANUFACTURE.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT THE CATHETER WAS FOUND TO BE BROKEN WHEN THE EEG WAS REMOVED AND THE TEGADERM WAS LIFTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    618827 UNKNOWN CATHETER SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG MEDTRONIC NEUROSURGERY UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR