BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDINAL

    MDR report key: 2832967 · Received October 31, 2012

    Report

    Report Number
    1216735-2012-00001
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Date of Event
    August 30, 2012
    Report Date
    October 24, 2012
    Manufacturer
    PURITAN MEDICAL PRODUCTS COMPANY LLC
    Product Code
    KXG
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    WE ARE UNABLE TO REPRODUCE THE CLAIMED DEFECT FROM OUR RETENTION SAMPLES, IN HOUSE PRODUCT TESTING AND REVIEW OF HISTORY INSPECTION BATCH RECORDS. (B)(4). THIS INCIDENT IS RECORDED IN OUR TREND ANALYSIS SYSTEM AND WE WILL MONITOR FOR EQUIVALENT EVENTS.

    Description of Event or Problem · 1

    PHYSICIAN USING APPLICATOR TO CLEAN OUT A TROCAR AND A PIECE OF THE COTTON CAME OFF THE SWAB AND ENTERED THE PATIENT ABDOMINAL CAVITY. THE COTTON WAS RETRIEVED. THE INCIDENT OCCURRED IN AUGUST. NO LOT NUMBER OR SAMPLE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARDINAL STERILE ABSORBENT TIPPED APPLICATOR KXG PURITAN MEDICAL PRODUCTS COMPANY LLC C15053-006 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other