BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEUROVENT-P

    MDR report key: 6345022 · Received February 21, 2017

    Report

    Report Number
    3006942548-2017-00001
    Event Type
    Malfunction
    Date Received
    February 21, 2017
    Date of Event
    January 3, 2017
    Report Date
    January 23, 2017
    Manufacturer
    RAUMEDIC AG
    Product Code
    GWM
    PMA / PMN Number
    K103206
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER STATEMENT: FOR EVALUATION OF THE MALFUNCTION DHR DOCUMENTS WERE REVIEWED. THEY DEMONSTRATE THAT THE CATHETER NEUROVENT-P (LOT E8228663) MET SPECIFICATION DURING MANUFACTURING. FINAL INSPECTION OF THE FINISHED CATHETER, WHICH ALSO COMPRISES INSPECTION OF BONDING, WAS PASSED. THIS DEMONSTRATES THAT THE CATHETER HAS BEEN MANUFACTURED AND SOLD IN CONFORMANCE TO RELEVANT SPECIFICATIONS. FURTHERMORE RETURNED CATHETER WAS INVESTIGATED. THIS INVESTIGATION DEMONSTRATES THAT THE ADHESIVE WAS CORRECTLY APPLIED. BASED ON KNOWLEDGE THAT THE FINAL INSPECTION OF THE FINISHED CATHETER WAS PASSED, THAT THE CATHETER WAS DELIVERED WITH PROPER FUNCTIONALITY AND IN CONSIDERATION OF THE RESULTS OF PERFORMED INVESTIGATION OF RETURNED CATHETER, THE DETACHING OF THE CATHETER TIP IS CAUSED BY USER ERROR WHILE EXPLANTATION BECAUSE SUTURES HAVEN'T BEEN LOOSENED PRIOR EXPLANTATION CONTRARY TO IFU.

    Description of Event or Problem · 1

    ON (B)(6) 2017 THE CLINIC CONTACTED RAUMEDIC SALES EMPLOYEE RELATING TO THE FOLLOWING INFORMATION: ON (B)(6) 2016 A CATHETER WAS APPLIED VIA TUNNEL. WITHOUT PRIOR LOOSENING OF SUTURES THE TUNNELED CATHETER WAS EXPLANTED ON (B)(6) 2017. ON REMOVAL OF THE IMPLANTED CATHETER THROUGH THE TUNNEL/ SKIN THE CATHETER TIP DETACHED AND REMAINED BEHIND. THE CATHETER TIP COULD BE REMOVED AND THE COMPLETE CATHETER WAS SENT TO RAUMEDIC FOR INVESTIGATION. CLINIC INFORMED THAT THE EVENT DID NOT CAUSE DETERIORATION OF THE PATIENTS HEALTH SITUATION AND ADMINISTRATION OF ADDITIONAL DRUGS WAS NOT NECESSARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    129970 NEUROVENT-P NEUROLOGICAL CATHETER GWM RAUMEDIC AG 092946-001 E8228663

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR