BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERTAS PLUS INLINE VALVE ONLY

    MDR report key: 17596155 · Received August 22, 2023

    Report

    Report Number
    3013886523-2023-00283
    Event Type
    Malfunction
    Date Received
    August 22, 2023
    Date of Event
    July 31, 2023
    Report Date
    October 13, 2023
    Manufacturer
    INTEGRA LIFESCIENCES SWITZERLAND SAR
    Product Code
    JXG
    UDI-DI
    10381780521013
    PMA / PMN Number
    K143111
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: D4, D9, G3, G6, H2, H3, H4, H6, H10. THE CERTAS VALVE ((B)(6)) WAS RETURNED FOR EVALUATION. DEVICE HISTORY RECORD (DHR) - PRODUCT CODE 82-8800PL WITH LOT 7052647 CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK. FAILURE ANALYSIS - THE POSITION OF THE CAM WHEN VALVE WAS RECEIVED WAS AT SETTING 4. THE VALVE WAS VISUALLY INSPECTED, THE INNER BLISTER LID WAS SEALED WITH TAPE THE TAPE WAS CUT AND BLISTER LID REMOVED, A HAIR WAS FOUND ON THE UNDERSIDE OF THE VALVE. NOT VISIBLE FROM THE BLISTER SIDE. ROOT CAUSE ANALYSIS- THE ROOT CAUSE FOR THE ISSUE REPORTED BY THE CUSTOMER IS DUE TO HUMAN ERROR. THE MANUFACTURING DEPARTMENT WERE INFORMED OF THE ISSUE AND AN AWARENESS WAS PERFORMED.

    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.

    Description of Event or Problem · 0

    N/A

    Description of Event or Problem · 0

    2 OF 2 REPORTS. OTHER MFG REPORT NUMBER: 3013886523-2023-00282. A FACILITY REPORTED A HAIR IN THE STERILE PACKAGING OF A CERTAS VALVE (ID 828800PL) AND THE BACTISEAL VENTRICULAR CATHETER (ID 823073) WAS CONTAMINATED BECAUSE OF THE ASSOCIATED CONTAMINATED VALVE. IT WAS DISCOVERED DURING SETUP FOR A VP SHUNT CASE ON (B)(6) 2023 AND THE PROCEDURE WAS COMPLETED WITH A REPLACEMENT PRODUCT AVAILABLE. NO PATIENT CONTACT/INJURY AND THE EVENT DID NOT LED TO SURGICAL DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300789 CERTAS PLUS INLINE VALVE ONLY CERTAS PLUS JXG INTEGRA LIFESCIENCES SWITZERLAND SAR 7052647 10381780521013

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown