BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CERTAS PLUS INLINE WITH SIPHON

    MDR report key: 15422030 · Received September 14, 2022

    Report

    Report Number
    3013886523-2022-00430
    Event Type
    Injury
    Date Received
    September 14, 2022
    Report Date
    December 5, 2022
    Manufacturer
    INTEGRA LIFESCIENCES SWITZERLAND SAR
    Product Code
    JXG
    UDI-DI
    10381780521174
    PMA / PMN Number
    K143111
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    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

    THE CERTAS VALVE WAS RETURNED FOR EVALUATION. DEVICE HISTORY RECORD (DHR) - THE PRODUCT CODE 82-8804PL WITH LOT 6180907, CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK. FAILURE ANALYSIS - THE POSITION OF THE CAM WHEN VALVE WAS RECEIVED WAS AT SETTING 1. THE VALVE WAS VISUALLY INSPECTED, SMALL CUT/TEAR/NEEDLE HOLES IN THE NEEDLE CHAMBER WERE NOTED. THE VALVE WAS HYDRATED. THE VALVE WAS LEAKED TESTED A LEAKED FROM THE SMALL CUT/TEAR/NEEDLE HOLES IN THE NEEDLE CHAMBER. THE VALVE PASSED THE TEST FOR PROGRAMMING, OCCLUSION, REFLUX, SIPHON GUARD AND PRESSURE. THE ROOT CAUSE FOR THE FAILED LEAKAGE TEST IS DUE TO THE SMALL CUT/TEARS/NEEDLE HOLE IN THE NEEDLE CHAMBER. THE ROOT CAUSE FOR THE SMALL CUT/TEARS/NEEDLE HOLE IN THE NEEDLE CHAMBER IS DUE TO A SHARP OR POINTED OBJECT COMING INTO CONTACT WITH THE SILICONE HOUSING, AS NOTED IN THE "IFU" SILICONE HAS A LOW CUT/TEAR RESISTANCE. THE POSSIBLE ROOT CAUSE FOR THE ISSUE REPORTED BY THE CUSTOMER COULD HAVE BEEN DUE TO THE SMALL CUT/TEARS/NEEDLE HOLE IN THE NEEDLE CHAMBER.

    Description of Event or Problem · 0

    A NURSE REPORTED A CERTAS VALVE (ID 828804PL) WAS IMPLANTED IN A 70-YEAR OLD MALE PATIENT IN (B)(6) 2022 WITH UNKNOWN SETTING. AN UNKNOWN FAILURE OCCURRED AFTER IMPLANTATION AND THE VALVE WAS EXPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2497881 CERTAS PLUS INLINE WITH SIPHON CERTAS PLUS W/ SG JXG INTEGRA LIFESCIENCES SWITZERLAND SAR 828804PL 6180907 10381780521174

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown