BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM TRAUMA KIT, PACK 000057

    MDR report key: 5044601 · Received September 1, 2015

    Report

    Report Number
    5044601
    Event Type
    Malfunction
    Date Received
    September 1, 2015
    Date of Event
    August 12, 2015
    Report Date
    August 28, 2015
    Manufacturer
    PROFESSIONAL HOSPITAL SUPPLY INC
    Product Code
    LRO
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    FOUND HAIR IN THE PHS CUSTOM TRAUMA PACK. THIS WAS IDENTIFIED PRIOR TO THE PATIENT COMING INTO THE OPERATING ROOM. THE CUSTOM BASIN SET ALSO HAD TO BE REMOVED AS WELL. HAIR FOUND ON OUTSIDE OF RED NEEDLE MAT. TAPE WAS PLACED OVER THE HAIR FOR VENDOR TO SEE. THIS FACILITY HAS HAD MULTIPLE DIFFERENT CUSTOM PRODUCTS FROM THIS MANUFACTURER WITH SIMILAR ISSUES OF FOREIGN SUBSTANCES, HAIR, ETC. FOUND IN THE PRODUCT PRIOR TO USE ON A PATIENT. THE MANUFACTURER HAS BEEN NOTIFIED AND PRODUCT HAS BEEN RETURNED. MANUFACTURER RESPONSE FOR 8122015A, (BRAND NOT PROVIDED) (PER SITE REPORTER): TO RESPOND TO THESE ISSUES, WE HAVE EXAMINED ALL OF OUR DRESS CODE, HYGIENE, AND HOUSEKEEPING CONTROLS. FROM THIS EXAMINATION, WE IDENTIFIED AN OPPORTUNITY TO IMPROVE OUR GOWNING AND HAIR COVER SOLUTIONS. PARTICULATE ISSUES ARE BEING ADDRESSED BY OUR PRODUCTION DEPARTMENT WITH AN OPEN CAR (B)(4) (CORRECTIVE ACTION REQUEST). FOR ADDITIONAL MEASURES, WE HAVE IMPLEMENTED A HIGH AWARENESS INSPECTION ALERT FOR THE FUTURE BUILDS OF THE AFFECTED CUSTOM STERILE PACKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    577096 CUSTOM TRAUMA KIT, PACK 000057 TRAY, SURGICAL LRO PROFESSIONAL HOSPITAL SUPPLY INC 1178353

    Patients

    Seq Age Sex Outcome Treatment
    1