BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROG VALVE INLINE W SG

    MDR report key: 8496442 · Received April 9, 2019

    Report

    Report Number
    1226348-2019-00066
    Event Type
    Injury
    Date Received
    April 9, 2019
    Date of Event
    March 19, 2019
    Report Date
    March 21, 2019
    Manufacturer
    RAYNHAM
    Product Code
    JXG
    PMA / PMN Number
    K053107
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    UDI (B)(4). DHR - REVIEW OF THE HISTORY DEVICE RECORDS FOR THE VALVE, PRODUCT CODE (B)(4). WITH LOT 211452 CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK ON THE (B)(6) 2018. FAILURE ANALYSIS THE VALVE PASSED ALL TESTS NO ROOT CAUSE COULD BE DETERMINED; AS NO FUNCTIONAL PROBLEM WAS NOTED WITH THE VALVE.

    Description of Event or Problem · 0

    N/A.

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED INCIDENT IS NOT AVAILABLE FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    A SALES REPRESENTATIVE REPORTED THAT ON (B)(6) 2019, THE PHYSICIAN ATTACHED THE VALVE (ID (B)(4) - PROG VALVE INLINE W SG) TO THE PATENT AND DID NOT SEE FLOW THROUGH THE VALVE. THE COORDINATOR INDICATED THAT THE VALVE HAD BEEN PRIMED. THE VALVE WAS REPLACED AND THE SECOND ONE FLOWED FREELY. THERE WAS NO PATIENT HARM AND A 10 MINUTE DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288625 PROG VALVE INLINE W SG CHPV WITH SG JXG RAYNHAM 211452

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR