BEUDAMED
    FDA Adverse Event Death Summary report: N

    ON-Q ANTIMICROBIAL CATHETER

    MDR report key: 7221864 · Received January 25, 2018

    Report

    Report Number
    MW5074913
    Event Type
    Death
    Date Received
    January 25, 2018
    Date of Event
    December 28, 2017
    Report Date
    January 24, 2018
    Manufacturer
    HALYARD HEALTH, INC.
    Product Code
    BSO
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    INTRAOPERATIVE CARDIOPULMONARY ARREST AND DEATH DURING PECTUS EXCAVATUM SURGERY WITH USE OF THE HALYARD ON-Q ANTIMICROBIAL CATHETER. DATES OF USE: (B)(6) 2017 BETWEEN 0613 AND 1314. DIAGNOSIS OR REASON FOR USE: ADMINISTRATION OF ANESTHESIA. IS THE PRODUCT COMPOUNDED: NO. IS THE PRODUCT OVER-THE-COUNTER: NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    61451 ON-Q ANTIMICROBIAL CATHETER ON-Q PUMP BSO HALYARD HEALTH, INC. PM020 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Death