BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INLINE PRECISION VALVE SG, M

    MDR report key: 3823915 · Received May 21, 2014

    Report

    Report Number
    1226348-2014-11623
    Event Type
    Malfunction
    Date Received
    May 21, 2014
    Date of Event
    September 13, 2013
    Manufacturer
    CODMAN & SHURTLEFF
    Product Code
    JXG
    PMA / PMN Number
    PK992173
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    AN INITIAL MEDWATCH IS BEING GENERATED TO FILE THIS COMPLAINT AS A MALFUNCTION. UPON COMPLETION OF THE INVESTIGATION, THE DEVICE WAS VISUALLY AND FUNCTIONALLY TESTED AND WAS FOUND TO WORK IN ACCORDANCE WITH THE MANUFACTURING SPECIFICATIONS. THE PROBLEM REPORTED BY THE CUSTOMER COULD NOT BE DUPLICATED IN THE LABORATORY SETTING. A REVIEW OF THE DEVICE HISTORY RECORDS CONFIRMED THAT THIS DEVICE CONFORMED TO THE REQUIRED SPECIFICATIONS PRIOR TO DISTRIBUTIONS. BASED ON THE RESULTS OF THIS INVESTIGATION NO FURTHER ACTION IS REQUIRED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME THIS COMPLAINT IS CLOSED.

    Description of Event or Problem · 1

    AFFILIATE REPORTED THAT DURING AN INTRA-OPERATIVE PROCEDURE AND ONCE VALVE CONNECTED TO VENTRICULAR CATHETER THERE WAS NO FLOW THROUGH THE PERIPHERAL EXIT OF THE VALVE. CHECKED AND DISCONNECTED ANOTHER NEW DEVICE. THEN CHOSEN WHICH WORKED IMMEDIATELY. BOTH SYSTEMS READ MEDIUM LOW PRESSURE. THE DYSFUNCTIONING VALVE WAS CHECKED ON A SEPARATE TABLE WITH A COLUMN OF FLUID AND GREATER PRESSURE. BOTH FAILED TO MAKE VALVE PATENT. ESSENTIALLY THERE WAS CSF FLOW THROUGH THE VENTRICULAR CATH BUT WHEN CONNECTED TO THE VALVE THERE WAS NO FLOW. HE DID MENTION THAT PERHAPS DEBRIS MAY HAVE CAUSED A BLOCKAGE AS THE SECOND VALVE WORKED FINE BUT WANTED IT CHECKED. (B)(4) NO SIGNIFICANT DELAY. (B)(4) NO DELAY GREATER THAN 30 MINUTES. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303184 INLINE PRECISION VALVE SG, M SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF CPDCTR

    Patients

    Seq Age Sex Outcome Treatment
    1