BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRA SURGICAL GWN XLG

    MDR report key: 5660427 · Received May 17, 2016

    Report

    Report Number
    3011270181-2016-00011
    Event Type
    Malfunction
    Date Received
    May 17, 2016
    Date of Event
    April 19, 2016
    Report Date
    June 16, 2016
    Manufacturer
    HALYARD HEALTH
    Product Code
    FYA
    PMA / PMN Number
    PK080795
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL COMPLAINT PRODUCT WAS RETURNED FOR EVALUATION. PER VISUAL INSPECTION, THERE IS A 0.8CM TEAR IN THE PAPER SIDE POUCH OF THE PACKAGING. THE PAPER AROUND THE HOLE IS JAGGED. A REVIEW OF THE MANUFACTURING PROCESS WAS PERFORMED, AND THE ROOT CAUSE WAS DETERMINED TO BE OPERATOR ERROR DURING THE PACKAGING PROCESS. CORRECTIVE ACTION HAS BEEN PERFORMED. THE DEVICE HISTORY RECORD FOR VN534304, WAS REVIEWED AND THE PRODUCT WAS PRODUCED ACCORDING TO PRODUCT SPECIFICATIONS. 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 COMP- (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE ACTUAL COMPLAINT PRODUCT WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD IS IN-PROGRESS. 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 (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE STERILE PACKAGING HAD A 1CM TEAR IN IT. THE TEAR WAS FOUND PRIOR TO USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    316799 ULTRA SURGICAL GWN XLG ULTRA SURGICAL GOWN & FLUID BARRIER SURGICAL GOWN FYA HALYARD HEALTH 78055 VN534304

    Patients

    Seq Age Sex Outcome Treatment
    1