BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAKIM PROG VALVE INLINE SIPHONGUARD

    MDR report key: 4102189 · Received September 19, 2014

    Report

    Report Number
    1226348-2014-11994
    Event Type
    Injury
    Date Received
    September 19, 2014
    Date of Event
    September 12, 2014
    Manufacturer
    CODMAN & SHURTLEFF, INC.
    Product Code
    JXG
    PMA / PMN Number
    PK992173
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UPON COMPLETION OF THE INVESTIGATION, A FOLLOW UP REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED FOR EVALUATION. THE INVESTIGATION OF THE RETURNED DEVICE DID CONFIRM THE PROBLEM REPORTED BY THE CUSTOMER. THE LOT NUMBER IS CMMB5H, SERIAL NUMBER (B)(4), PRODUCT CODE 82-3842. THE POSITION OF THE CAM WHEN VALVE WAS RECEIVED WAS 140MMH2O. THE VALVE WAS VISUALLY INSPECTED AND CONFIRMED THAT THE SIPHON GUARD WAS NO LONGER ATTACHED TO THE VALVE. THIS COULD BE DUE TO A SHARP OR POINTED OBJECT COMING INTO CONTACT WITH THE SILICONE HOUSING, BUT THIS COULD NOT BE DETERMINED. REVIEW OF THE HISTORY DEVICE RECORDS CONFIRMED THE VALVE, PRODUCT CODE 82-3842, WITH LOT NUMBER CMMB5H, CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK ON THE 15TH NOVEMBER 2011. THE ROOT CAUSE OF THE PROBLEM REPORTED BY THE CUSTOMER COULD BE DUE TO A SHARP OR POINTED OBJECT COMING INTO CONTACT WITH THE SILICONE HOUSING. NO CORRECTIVE ACTION IS NEEDED BASED ON THE RESULTS OF THE EVALUATION. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME THIS COMPLAINT IS CONSIDERED CLOSED. AS NOTED IN THE IFU: WARNINGS SILICONE HAS A LOW CUT AND TEAR RESISTANCE; THEREFORE, EXERCISE CARE WHEN PLACING LIGATURES SO AS NOT TO TIE THEM TOO TIGHTLY. THE USE OF STAINLESS STEEL LIGATURES ON SILICONE RUBBER IS NOT RECOMMENDED. DO NOT USE SHARP INSTRUMENTS WHEN HANDLING THE SILICONE VALVE OR CATHETER; USE SHOD FORCEPS. CUTS OR ABRASIONS FROM SHARP INSTRUMENTS MAY RUPTURE OR TEAR THE SILICONE COMPONENTS.

    Description of Event or Problem · 1

    THE PRODUCT WAS IMPLANTED VIA V-P SHUNT. DOI AND SETTING PRESSURE ARE UNKNOWN. SINCE THE VALVE WAS FOUND BROKEN, THE PRODUCT WAS REMOVED ON (B)(6) 2014. THE PATIENT¿S CONDITION IS REPORTED AS GOOD. MORE DETAILED INFORMATION WILL BE PROVIDED AS SOON AS (B)(4) RECEIVES FROM THE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    583925 HAKIM PROG VALVE INLINE SIPHONGUARD SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF, INC. CMMB5H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention