BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROG VALVE CLYNDRICAL W PRECHA

    MDR report key: 16416764 · Received February 22, 2023

    Report

    Report Number
    3013886523-2023-00048
    Event Type
    Malfunction
    Date Received
    February 22, 2023
    Date of Event
    January 30, 2023
    Report Date
    May 3, 2023
    Manufacturer
    INTEGRA LIFESCIENCES SWITZERLAND SAR
    Product Code
    JXG
    UDI-DI
    10381780519133
    PMA / PMN Number
    K122118
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE HAKIM VALVER (ID 823110) WAS RETURNED FOR EVALUATION. DEVICE HISTORY RECORD (DHR) - THE PRODUCT CODE 82-3110 WITH LOT 6498231, CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK. FAILURE ANALYSIS - -THE POSITION OF THE CAM WHEN VALVE WAS RECEIVED WAS 150MMH2O. THE VALVE WAS VISUALLY INSPECTED; A CUT/TEAR WAS NOTED IN THE VENTRICULAR CATHETER NEAR THE VALVE, ALSO A CUT/TEAR IN THE SILICONE HOUSING OF THE VALVE NEAR THE DISTAL CONNECTOR ON THE SIDE OF THE VALVE. HE VALVE WAS LEAK TESTED; LEAKED FROM THE DAMAGED SILICONE HOUSING. THE COMPLAINT IS CONFIRMED. THE ROOT CAUSE FOR THE ISSUE REPORTED BY THE CUSTOMER IS PROBABLY DUE TO THE LEAKAGE NOTED DURING THE INVESTIGATION. THE ROOT CAUSE FOR THE LEAKAGE NOTED DURING THE INVESTIGATION IS DUE TO A SHARP OR POINTED OBJECT COMING INTO CONTACT WITH THE SILICONE, AS NOTED IN THE IFU, SILICONE HAS A LOW CUT/TEAR RESISTANCE.

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    A FACILITY REPORTED THAT AFTER CONNECTING THE PERITONEAL AND VENTRAL CATHETERS OF A HAKIM VALVE (ID (B)(4)), THERE IS A LOW FLOW OF WATER IN THE CHAMBER PART. WHEN TESTING THE ACTUAL VALVE THE FAILURE WAS NOT SHOWING; HOWEVER, A MICRO-CHECK IS REQUIRED. THE PROCEDURE WAS COMPLETED WITH A REPLACEMENT PRODUCT AVAILABLE. NO PATIENT CONTACT OR INJURY WAS REPORTED; HOWEVER, THE EVENT LED TO 3 HOURS SURGICAL DELAY. THE VALVE WAS USED TO TREAT HYDROCEPHALUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1643661 PROG VALVE CLYNDRICAL W PRECHA CHPV JXG INTEGRA LIFESCIENCES SWITZERLAND SAR 823110 6498231 10381780519133

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown