BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROG VALVE INLINE W SG

    MDR report key: 8581925 · Received May 6, 2019

    Report

    Report Number
    1226348-2019-00131
    Event Type
    Malfunction
    Date Received
    May 6, 2019
    Date of Event
    April 18, 2019
    Report Date
    April 23, 2019
    Manufacturer
    RAYNHAM
    Product Code
    JXG
    PMA / PMN Number
    K041296
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    UDI INFORMATION (B)(4). SAMPLE WAS RECEIVED FOR EVALUATION. THE VALVE WAS VISUALLY INSPECTED; A CUT/TEAR IN THE SILICONE HOUSING IN THE NEEDLE CHAMBER WAS NOTED. THE POSITION OF THE CAM WHEN VALVE WAS RECEIVED WAS 140MMH2O. THE TECHNICIAN WAS ABLE TO CONFIRM THE PROBLEM REPORTED BY THE CUSTOMER. THE ROOT CAUSE FOR THE CUT/TEAR SILICONE HOUSING IS DUE TO A POINTED OR SHARP OBJECT COMING INTO CONTACT WITH THE SILICONE HOUSING. AS NOTED IN THE IFU SILICONE HAS A LOW TEAR/CUT RESISTANCE. MANUFACTURING RECORDS WERE REVIEWED AND FOUND NO ANOMALIES. BASED ON THE RESULTS OF THE INVESTIGATION, THE REPORTED ISSUE IS CONFIRMED. 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

    TO DATE THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT THE VALVE (ID 823162-PROG VALVE INLINE W SG) WAS PREPPED FOR USE ON (B)(6) 2019. IT WAS CONFIRMED THAT THE VALVE HAD NO PROBLEM WHEN THE AIR WAS REMOVED. HOWEVER WHEN THE VALVE WAS ABOUT TO BE IMPLANTED, THE SALINE WAS LEAKED FROM THE RESERVOIR. THEREFORE THE SURGEON REPLACED IT WITH A NEW VALVE AND THERE WAS NO ISSUE CONFIRMED. THE SURGEON REQUESTED AN INVESTIGATION REPORT. THERE WAS NO SURGICAL DELAY AND THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED BY HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    376907 PROG VALVE INLINE W SG CHPV WITH SG JXG RAYNHAM 3240361

    Patients

    Seq Age Sex Outcome Treatment
    1