BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROG VALVE INLINE W SG

    MDR report key: 11572343 · Received March 25, 2021

    Report

    Report Number
    3013886523-2021-00131
    Event Type
    Malfunction
    Date Received
    March 25, 2021
    Date of Event
    February 12, 2021
    Report Date
    June 2, 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

    UPDATED FIELDS:  D4, D9, G3, G6, H2, H3, H4, H6, H10. THE VALVE WAS RETURNED FOR EVALUATION. DEVICE HISTORY RECORD (DHR) - PRODUCT CODE 82-3162 WITH LOT 3214676, CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK. FAILURE ANALYSIS - IT WAS NOT POSSIBLE TO INVESTIGATE AS ONLY THE VALVE WAS RETURNED IN A PLASTIC TUB NO PACKAGING WAS RETURNED FOR INVESTIGATION. AS NO DEFECT WAS REPORTED ON THE VALVE THIS WAS NOT INVESTIGATED. NO ROOT CAUSE COULD NOT BE DETERMINED AS THE NO PACKAGING WAS RETURNED FOR INVESTIGATION. THE POSSIBLE ROOT CAUSE FOR THE PACKAGING ISSUE REPORTED BY THE CUSTOMER COULD BE DUE TO HANDLING/STORAGE/TRANSPORT.

    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

    2 OF 2 REPORTS. SAME PROCEDURE, DIFFERENT PRODUCTS. OTHER MFG REPORT NUMBER: 3013886523-2021-00130 A FACILITY REPORTED A DAMAGED PACKAGE OF A HAKIM VALVE. DURING PROCEDURE, THE NURSE FOUND THAT THE PACKAGE OF THE VALVE WAS DAMAGED. THEREFORE, THE PHYSICIAN STOP IMPLANTING IT AND CHANGED TO A NEW HAKIM VALVE AND THE PROCEDURE WAS COMPLETED. A 15 MINUTE DELAY WAS NOTED WITH NO ADVERSE CONSEQUENCE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    468547 PROG VALVE INLINE W SG CHPV WITH SG JXG INTEGRA LIFESCIENCES SWITZERLAND SAR 3214676

    Patients

    Seq Age Sex Outcome Treatment
    1