BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDLINE INDUSTRIES, INC.

    MDR report key: 11803066 · Received May 10, 2021

    Report

    Report Number
    1423395-2021-00027
    Event Type
    Malfunction
    Date Received
    May 10, 2021
    Date of Event
    April 13, 2021
    Report Date
    May 10, 2021
    Manufacturer
    MEDLINE INDUSTRIES INC.
    Product Code
    FDE
    UDI-DI
    10193489264234
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    EMAIL RECEIVED BY FACILITY REPRESENTATIVE, (B)(6) HOSPITAL, WITH ADDITIONAL INFORMATION RELATED TO THIS REPORTED INCIDENT. REPORTER STATES, FIBERS OF THE RAYTEC/GAUZE WERE NOTED TO BE COMING APART/SHREDDING INTO THE BREAST/AXILLARY SURGICAL SITE DURING A BREAST SURGERY PROCEDURE. REPORTER CONFIRMS THE RAYTEC/GAUZE SPONGES WERE "MOST LIKELY SOMETIME THROUGH THE CASE ONE USED TO WIPE THE INSTRUMENTS." REPORTER STATES SURGEON PICKED OUT FIBERS BY HAND, IRRIGATION AND FORCEPS. ALL FIBERS WERE REPORTED TO BE REMOVED FROM THE PATIENT'S SURGICAL SITE. NO REPORT OF SERIOUS INJURY. REPORTER STATES, "NO POST-OPERATIVE COMPLICATIONS HAVE BEEN REPORTED AT THIS TIME." SAMPLES HAVE BEEN RETURNED FOR EVALUATION. INVESTIGATION SUMMARY READS AS FOLLOWS; "THE ACCOUNT REPORTED FINDING RAYTEC SPONGES ARE SHREDDING. THE REPORTED ISSUE OCCURRED IN ITEM DYNJ44723D (LOT 21BDB918). BASED ON THE INFORMATION PROVIDED, THE REPORTED ISSUE APPEARS TO BE A VENDOR PRODUCT ISSUE." DUE TO THE REPORTED INCIDENT, MEDICAL INTERVENTION AND IN AN ABUNDANCE OF CAUTION, THIS MED WATCH IS BEING FILED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MED WATCH WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED; RAYTEC/GAUZE SPONGES ARE SHREDDING FROM THE LAPAROSCOPY BASIN PACKS AND LEAVING SMALL PIECES OF GAUZE IN THE WOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    700018 MEDLINE INDUSTRIES, INC. LAPAROSCOPY BASIN PACK FDE MEDLINE INDUSTRIES INC. DYNJ44723D 21BDB918 10193489264234

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention