BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURGPN,270X4,P.ONLY,-,OQ,5

    MDR report key: 5770528 · Received July 5, 2016

    Report

    Report Number
    2026095-2016-00087
    Event Type
    Malfunction
    Date Received
    July 5, 2016
    Report Date
    June 8, 2016
    Manufacturer
    HALYARD - IRVINE
    Product Code
    MEB
    PMA / PMN Number
    PK063530
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ACTUAL DEVICE WAS NOT RETURNED. THE DEVICE HISTORY RECORD FOR THE REPORTED LOT NUMBER, 0202352654, WAS REVIEWED AND DOCUMENTED THAT THE LOT WAS MANUFACTURED ACCORDING TO THE APPROVED MANUFACTURING PROCEDURES, SPECIFICATIONS, AND THEN RELEASED BY QUALITY ASSURANCE. HALYARD HEALTH HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE HALYARD HEALTH COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4).

    Description of Event or Problem · 1

    FILL VOLUME: 270 ML. FLOW RATE: 4ML/HR. PROCEDURE: MID FOOT OSTEOTOMY. CATHPLACE: SCIATIC NERVE BLOCK. A REPORT WAS RECEIVED STATING THE ONQ PUMP EMPTIED PREMATURELY. THE PUMP EMPTIED ABOUT 24-HOURS PREMATURELY. THE ONQ CATHETER WAS CONNECTED TO THE NERVE BLOCK AT (B)(6) 2016 AT 1130 AM. THE ONQ WAS SET UP CORRECTLY AND THE FLOW REGULATOR WAS SECURED TO SKIN WITH A TEGADERM. THE PATIENT WAS KEPT IN THE HOSPITAL UNTIL (B)(6) 2016. ON ROUNDS AT 8:00AM ON (B)(6) 2016, THE ONQ WAS NOTED TO BE EMPTY, LASTING ONLY 44.5 HOURS).THE DRESSING, ONQ SET UP AND FLOW REGULATOR WERE ALL IN TACT AND APPROPRIATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    424754 SURGPN,270X4,P.ONLY,-,OQ,5 ELASTOMERIC LFR MEB HALYARD - IRVINE P270X4 0202352654

    Patients

    Seq Age Sex Outcome Treatment
    1