BEUDAMED
    FDA Adverse Event Other Summary report: N

    CHURCHILL MEDICAL SYSTEMS

    MDR report key: 1416669 · Received May 5, 2009

    Report

    Report Number
    1223004-2009-00001
    Event Type
    Other
    Date Received
    May 5, 2009
    Date of Event
    March 16, 2009
    Report Date
    May 5, 2009
    Product Code
    LRS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    AMS-796CP, LOT # 810124 CONTAINED CHLORAPREP FREPP (PART # 260599NSB), LOT # 030714A (24896) AND 030966B (25900). CARDINAL HEALTH IS THE SUPPLIER. (B)(4) FROM CARDINAL WAS CONTACTED ON (B)(4) 2009; SHE WAS NOTIFIED ABOUT THE COMPLAINT DIRECTLY FROM THE HOSPITAL. THE HOSPITAL WILL FORWARD THE DEVICE DIRECTLY TO CARDINAL. CARDINAL WILL PROVIDE VYGON A COPY OF THE INVESTIGATION REPORT ONCE THE INVESTIGATION HAS BEEN COMPLETED. A MEDWATCH REPORT WAS REPORTED BY THE HOSPITAL, VYGON RECEIVED A COPY OF THIS MEDWATCH ON (B)(4) 2009. VYGON HAD PREVIOUSLY DETERMINED THE EVENT NOT TO BE REPORTABLE, BECAUSE THE CUT DESCRIBED IN THE REPORT WAS SUPERFICIAL.

    Description of Event or Problem · 1

    "DURING AN IV START FOR SURGERY, THE CHLORAPREP FREPP SPONGE WAS ACTIVATED AND GLASS FRAGMENTS WERE IN THE SPONGE LEADING TO A SUPERFICIAL CUT ON THE PATIENT'S ARM."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CHURCHILL MEDICAL SYSTEMS KIT, IV SITE PREP LRS AMS - 796CP 810124

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Other