BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGPN,270X5,PBI,-,OQI,5

    MDR report key: 5724607 · Received June 14, 2016

    Report

    Report Number
    2026095-2016-00073
    Event Type
    Injury
    Date Received
    June 14, 2016
    Date of Event
    May 18, 2016
    Report Date
    May 19, 2016
    Manufacturer
    HALYARD - IRVINE
    Product Code
    MEB
    PMA / PMN Number
    PK063530
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UDI # UNKNOWN. THE ACTUAL COMPLAINT PRODUCT WAS NOT RETURNED FOR EVALUATION. THE DEVICE HISTORY RECORD FOR THE LOT NUMBER, 0202195126, INVOLVED IN THIS COMPLAINT WAS REVIEWED AND THE MATERIAL WAS PRODUCED ACCORDING TO THE MANUFACTURING PROCEDURES AND MET THE QUALITY REQUIREMENTS. 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). DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED FROM (B)(6) STATING THE PATIENT UNDERWENT A STERNOTOMY. DURING CATHETER INSERTION, THE PEEL AWAY SHEATH BROKE AND REMAINED INSIDE THE PATIENT. AND X-RAY WAS PERFORMED A LARGER INCISION WAS MADE TO SUCCESSFULLY RETRIEVE THE PLASTIC COMPONENT AND THE PATIENT REQUIRED A LONGER ANESTHETIC. THE CATHETER PLACEMENT WAS FOR A STERNAL INCISION PLACED UNDER THE LEFT BREAST TISSUE OF THE PATIENT, THEREFORE RETRIEVING IT WAS VERY DIFFICULT. THE SURGERY WAS DELAYED BY ONE HOUR. NO ADDITIONAL INFORMATION WAS PROVIDED IN REGARDS TO THE PATIENT'S STATUS AND THE OUTCOME OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379024 SURGPN,270X5,PBI,-,OQI,5 ELASTOMERIC LFR MEB HALYARD - IRVINE PS12504 0202304448

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention