BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAKIM PROGRAMMABLE VALVE WITH PRECHAMBER

    MDR report key: 5297828 · Received December 15, 2015

    Report

    Report Number
    1226348-2015-10750
    Event Type
    Malfunction
    Date Received
    December 15, 2015
    Date of Event
    November 24, 2015
    Manufacturer
    CODMAN & SHURTLEFF, INC. / MEDOS S.A.
    Product Code
    JXG
    PMA / PMN Number
    PK974739
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF THE INVESTIGATION IT WAS NOTED THAT THE CATHETER WAS VISUALLY INSPECTED AND CONFIRMS THE CUTS IN THE CATHETER AS REPORTED BY THE CUSTOMER. THE PERITONEAL CATHETER WAS RETURNED IN 2 PARTS, ALL 4 ENDS OF THE PERITONEAL CATHETER WERE CLEAN CUT. 2 CUTS WERE FOUND ON THE 520MM OF PERITONEAL CATHETER, THE CUTS WERE CLEAN CUT, POSSIBLY DONE BY A SCALPEL. REVIEW OF THE HISTORY DEVICE RECORDS CONFIRMED THE VALVE PRODUCT CODE 82-3114 WITH LOT CTDCDV, CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK IN (B)(4) 2015. THE ROOT CAUSE COULD BE DUE TO A SHARP OBJECT COMING INTO CONTACT WITH THE CATHETER, THIS HOWEVER COULD NOT BE DETERMINED. 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

    UPON COMPLETION OF THE INVESTIGATION A FOLLOW UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    ON (B)(6) 2015, DURING IMPLANTATION, THE SURGEON FOUND THE ABDOMINAL CATHETER HAD A SLIT. HE IMPLANTED THE SAME NEW DEVICE INSTEAD AND COMPLETED THE PROCEDURE WITHOUT FURTHER ISSUES. THE VALVE WAS DISCARDED AT THE FACILITY AND ONLY THE ABDOMINAL CATHETER WILL BE RETURNED FOR EVALUATION. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    825604 HAKIM PROGRAMMABLE VALVE WITH PRECHAMBER SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF, INC. / MEDOS S.A. CTCBF8

    Patients

    Seq Age Sex Outcome Treatment
    1