BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXACT-FLO IN-LINE (H) (5PK)

    MDR report key: 3801818 · Received May 9, 2014

    Report

    Report Number
    1226348-2014-11572
    Event Type
    Malfunction
    Date Received
    May 9, 2014
    Date of Event
    October 29, 2012
    Manufacturer
    CODMAN & SHURTLEFF
    Product Code
    JXG
    PMA / PMN Number
    PK973774
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UPON COMPLETION OF THE INVESTIGATION, IT WAS NOTED THAT THE VALVE IS A PRECISION VALVE WITH 4 DOTS. 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

    DOCTOR INFORMED THAT THE VALVE PRESENTED LEAK IN TOP OF SHUNT DURING THE PROCEDURE. DEVICE VALIDITY: (B)(4). ON (B)(6)2012, THE AFFILIATE INFORMED THAT THERE WAS NO ADVERSE EVENT TO THE PATIENT AND THERE WAS NOT ANY DELAY IN THE SURGERY GREATER THAN 30 MINUTES. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281948 EXACT-FLO IN-LINE (H) (5PK) SHUNT, CENTRAL NERVOUS SYTEM & COMPS JXG CODMAN & SHURTLEFF CMDBKT

    Patients

    Seq Age Sex Outcome Treatment
    1