BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPNG,GAUZE,4 IN X 4 IN,16 PLY,

    MDR report key: 19320170 · Received May 15, 2024

    Report

    Report Number
    1018120-2024-00009
    Event Type
    Malfunction
    Date Received
    May 15, 2024
    Report Date
    August 16, 2024
    Manufacturer
    CARDINAL HEALTH 200, LLC
    Product Code
    GDY
    UDI-DI
    0192253047230
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING SECTIONS WERE CORRECTED OR COMPLETED: BRAND NAME: VISTEC. MANUFACTURER NAME: CARDINAL HEALTH 200, LLC. UNIQUE IDENTIFIER (UDI) #: (B)(4). PMA/510(K)NUMBER: EXEMPT. LABELED FOR SINGLE USE: YES. INVESTIGATION SUMMARY: A PHOTO SAMPLE WAS RECEIVED FOR THE INVESTIGATION. THE DEVICE HISTORY RECORD WAS REVIEWED AND INDICATED THAT THE PRODUCT WAS RELEASED ACCOMPLISHING ALL QUALITY STANDARDS. UPON A VISUAL EVALUATION OF THE PHOTO SAMPLE, THE DEFECT WAS CONFIRMED; THE SELVAGE EDGE WAS UNFOLDED. A ROOT CAUSE ANALYSIS INDICATED THAT THIS OCCURRED DURING OUR MANUFACTURING PROCESS.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THE GAUZE XRAY IS SHEDDING SMALL WHITE THREADS. PER ADDITIONAL INFORMATION RECEIVED, IT IS UNKNOWN IF MEDICATION INTERVENTION WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1358737 SPNG,GAUZE,4 IN X 4 IN,16 PLY, GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE GDY CARDINAL HEALTH 200, LLC 7148 24A056362 0192253047230

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown