BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDOS PROG INFANT VALVESYSTEM

    MDR report key: 22608290 · Received July 25, 2025

    Report

    Report Number
    3013886523-2025-00184
    Event Type
    Malfunction
    Date Received
    July 25, 2025
    Date of Event
    June 25, 2025
    Report Date
    November 26, 2025
    Manufacturer
    INTEGRA LIFESCIENCES MANSFIELD
    Product Code
    JXG
    UDI-DI
    10381780519126
    PMA / PMN Number
    K221840
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: D4, D9, G3, G6, H2, H3, H4, H6, H11. THE HAKIM VALVE (ID: 823101) WAS RETURNED FOR EVALUATION. DEVICE HISTORY RECORDS (DHR) - THE PRODUCT CODE 823101 WITH LOT 7121721 SN UNKNOWN, CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK FAILURE ANALYSIS - THE DEVICE AND ALL PACKAGING WERE VISUALLY INSPECTED: NO HAIR, NO FIBROUS TISSUE WAS FOUND ON THE PAPER OF THE OPEN INNER AND OUTER LID OF THE BLISTER. A SPECIFIC PROCEDURE WAS STUDIED: IT NECESSARY TO CHECK THAT THE VALVE IS FREE FROM IMPURITIES. THE COMPLAINT IS NOT CONFIRMED. ROOT CAUSE ANALYSIS - NO ROOT CAUSE COULD BE DETERMINED AS THE TECHNICIAN COULD NOT CONFIRM ANY PROBLEM WITH THE VALVE AT THE TIME OF INVESTIGATION. THE POSSIBLE ROOT CAUSE FOR THE ISSUE REPORTED BY THE CUSTOMER, COULD BE DUE TO A HUMAN ERROR WRONG HANDLING IN THE OPERATING ROOM.

    Description of Event or Problem · 0

    A PHYSICIAN REPORTED A HAKIM VALVE (ID: (B)(6)) HAD BLACK FIBROUS MATERIAL RESEMBLING HAIR UPON OPENING THE STERILE PACKAGE. THE PROCEDURE WAS COMPLETED WITH A REPLACEMENT PRODUCT AVAILABLE. NO PATIENT INJURY WAS REPORTED, AND THE EVENT DID NOT LED TO SURGICAL DELAY.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1939429 MEDOS PROG INFANT VALVESYSTEM CHPV JXG INTEGRA LIFESCIENCES MANSFIELD 7121721 10381780519126

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown