BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROG VALVE INLINE W SG

    MDR report key: 11238725 · Received January 27, 2021

    Report

    Report Number
    3013886523-2021-00047
    Event Type
    Malfunction
    Date Received
    January 27, 2021
    Date of Event
    January 4, 2021
    Report Date
    March 3, 2021
    Manufacturer
    INTEGRA LIFESCIENCES SWITZERLAND SAR
    Product Code
    JXG
    PMA / PMN Number
    K041296
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE HAKIM VALVE WAS NOT RETURNED FOR EVALUATION (AS PER CUSTOMER, PRODUCT NOT AVAILABLE) THEREFORE, AN EVALUATION OF THE DEVICE COULD NOT BE PERFORMED. LOT NUMBER INFORMATION HAS BEEN PROVIDED; THEREFORE, MANUFACTURING RECORDS WERE REVIEWED AND FOUND NO ANOMALIES. THE CAUSE(S) OF THE DIFFICULTY REPORTED BY THE CUSTOMER COULD NOT BE DETERMINED. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE IN THE FUTURE, THIS COMPLAINT WILL BE REOPENED, AND THE RESPECTIVE EVALUATION PERFORMED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR ISSUES. AT PRESENT, WE CONSIDER THIS COMPLAINT TO BE CLOSED.

    Description of Event or Problem · 0

    N/A

    Additional Manufacturer Narrative · 1

    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 · 1

    A FACILITY REPORTED THAT A CODMAN HAKIM PROGRAMMABLE VALVE (823162) WAS GOING TO BE PLACED IN A (B)(6) FEMALE PATIENT. WHEN THE VALVE WAS ATTACHED TO THE DISTAL CATHETER, THE SURGEON CHECK FOR FLOW AND NOTED THAT THE SIPHONGUARD LOOKED ¿OUT OF ALIGNMENT... A BIT DISJOINTED¿ PRIOR TO BEING REMOVED FROM THE PACKAGE. HE THEN ATTACHED A MANOMETER TO TEST THE FLOW OF THE VALVE BUT WAS UNSATISFIED WITH THE FLOW RATE. THE VALVE WAS CHANGED TO A NEW CERTAS VALVE WITH SG (828804PL) AND WAS FOUND TO BE SATISFACTORY. THE QUESTIONABLE DEFECTIVE VALVE WAS HELD FOR FURTHER TESTING. A SURGICAL DELAY OF 15 MINUTES WAS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    131804 PROG VALVE INLINE W SG CHPV WITH SG JXG INTEGRA LIFESCIENCES SWITZERLAND SAR 161204

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR