BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROG VALVE INLINE W SG

    MDR report key: 11600169 · Received March 31, 2021

    Report

    Report Number
    3013886523-2021-00150
    Event Type
    Malfunction
    Date Received
    March 31, 2021
    Date of Event
    March 15, 2021
    Report Date
    May 6, 2021
    Manufacturer
    INTEGRA LIFESCIENCES SWITZERLAND SAR
    Product Code
    JXG
    PMA / PMN Number
    K041296
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS:  D4, D9, G3, G6, H2, H3, H4, H6, H10. THE HAKIM VALVE WAS RETURNED FOR EVALUATION. DEVICE HISTORY RECORD (DHR) - THE PRODUCT CODE 82-3162 WITH LOT NUMBER 4302815, CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK. FAILURE ANALYSIS - THE POSITION OF THE CAM WHEN VALVE WAS RECEIVED WAS 40MMH2O. THE VALVE WAS VISUALLY INSPECTED; IT WAS NOTED THE DISTAL CONNECTOR PART HAS BEEN BROKEN OFF FROM THE SIPHON GUARD. THE SILICONE HOUSING WAS VISUALLY INSPECTED, NO DEFECTS NOTED. THE SILICONE HOUSING WAS PEELED BACK TO REVEAL THE END OF THE SIPHON GUARD, THE CONNECTOR SEEMS TO HAVE BEEN SNAPPED OFF. THE CONNECTOR WAS VISUALLY INSPECTED, MARKS POSSIBLY FROM A CLAP OR FORCEPS WERE NOTED IN THE BROKEN OFF CONNECTOR. THE ROOT CAUSE FOR THE ISSUE REPORTED BY THE CUSTOMER, IS DUE TO WRONG HANDLING CLAMP OR FORCEPS MARKS WERE NOTED ON THE CONNECTOR.

    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 NURSE REPORTED THAT THE DISTAL END WHERE THE PERITONEAL CATHETER ATTACHES BROKE OFF DURING THE PROCEDURE. ANOTHER VALVE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY AND A FEW MINUTES SURGICAL DELAY REPORTED (TIME TO GET ANOTHER VALVE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    491865 PROG VALVE INLINE W SG CHPV WITH SG JXG INTEGRA LIFESCIENCES SWITZERLAND SAR 4302815

    Patients

    Seq Age Sex Outcome Treatment
    1