BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION VALVE INLINE, SIPHONGUARD

    MDR report key: 5537922 · Received March 31, 2016

    Report

    Report Number
    1226348-2016-10246
    Event Type
    Injury
    Date Received
    March 31, 2016
    Date of Event
    March 9, 2016
    Manufacturer
    CODMAN & SHURTLEFF, INC. / MEDOS S.A.
    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

    (B)(4). UPON COMPLETION OF THE INVESTIGATION IT WAS NOTED THAT THE IMAGES WERE TAKEN OF THE ¿AS RECEIVED¿ VALVE. THE VALVE IS A PRECISION VALVE WITH 3 DOTS. THE VALVE WAS HYDRATED FOR ABOUT 48 HOURS. THE VALVE WAS VISUALLY INSPECTED: AND CONFIRMS THE TEAR/CUT IN THE SILICONE HOUSING AROUND THE SIPHON GUARD. REVIEW OF THE HISTORY DEVICE RECORDS CONFIRMED THE VALVE PRODUCT CODE 82-3813, WITH LOT CPBB2F, CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK IN 19TH FEBRUARY 2013. THE ROOT CAUSE COULD BE DUE TO A SHARP OR POINTED OBJECT COMING INTO CONTACT WITH THE SILICONE, OR SOME FORM OF IMPACT, THIS HOWEVER COULD NOT BE DETERMINED. AS NOTED IN THE IFU SILICONE HAS A LOW TEAR / CUT RESISTANCE. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS NOT POSSIBLE TO INVESTIGATE THE COMPLAINT AS NO SAMPLE WAS RETURNED FOR EVALUATION. WE HAVE MADE SEVERAL PREVIOUS ATTEMPTS FOR TRACKING INFORMATION AND/OR TO HAVE THE COMPLAINT SAMPLE RETURNED TO US. IF THE SAMPLE IS RETURNED IN THE FUTURE, THIS COMPLAINT WILL BE RE-OPENED AND EVALUATED. REVIEW OF THE HISTORY DEVICE RECORDS CONFIRMED THE VALVE PRODUCT CODE 82-3813 WITH LOT CPBB2F CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK IN 19TH FEBRUARY 2013. AT THE PRESENT TIME THIS COMPLAINT IS CONSIDERED CLOSED. DEVICE NOT AVAILABLE.

    Description of Event or Problem · 1

    IN (B)(6) 2016 PATIENT UNDERWENT HYDROCEPHALUS SHUNT IMPLANTATION. TWO (2) WEEKS AFTER INITIAL IMPLANTATION CSF LEAKAGE WAS DIAGNOSED AROUND VALVE. DURING REVISION PROCEDURE ON (B)(6) 2016 IT WAS DISCOVERED THAT THE VALVE HAD A RIP CAUSING THE LEAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194330 PRECISION VALVE INLINE, SIPHONGUARD SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF, INC. / MEDOS S.A. CPBB2F

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention