BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDLINE

    MDR report key: 11681357 · Received April 16, 2021

    Report

    Report Number
    1417592-2021-00073
    Event Type
    Malfunction
    Date Received
    April 16, 2021
    Date of Event
    March 31, 2021
    Report Date
    April 16, 2021
    Manufacturer
    MEDLINE INDUSTRIES INC.
    Product Code
    FRL
    UDI-DI
    10080196282739
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED, "THE OPERATING ROOM (OR) TOWELS HAVING LINT/FIBERS & IT SPREAD ALL OVER TO THE SURGICAL GLOVES, INSTRUMENTS, DRAPES & POTENTIALLY ON THE PATIENT. THIS IS HAPPENING IN THE MIDDLE OF THE CASE." EMAIL RECEIVED BY BSN, RN, CNOR, UC (B)(6) MEDICAL CENTER, WITH ADDITIONAL INFORMATION RELATED TO THIS INCIDENT. REPORTER STATES ON (B)(6) 2021 "DURING AN ASCENDING AORTIC REPLACEMENT AND AORTIC VALVE REPLACEMENT PROCEDURE, THE LINT FROM THE TOWELS MADE CONTACT WITH THE OPEN SITE THROUGH THE SURGEON AND STAFF GLOVES." REPORTER STATES, "THE LINT WERE REMOVED BY PICKING IT WITH FORCEPS. IN ADDITION, STAFF REMOVED THE TOWELS AND GLOVES. THE SURGEON HAD TO PAUSE/STOPPED THE SURGERY AND REMOVED THE LINT AND DO FURTHER INSPECTION OF THE SEVERITY OF THE SITUATION. AS A RESULT, THE PATIENT DID REQUIRE ADDITIONAL GENERAL ANESTHESIA." NO SERIOUS INJURY HAS BEEN REPORTED AT THIS TIME. SAMPLES ARE NOT AVAILABLE FOR RETURN AND EVALUATION THEREFORE, A ROOT CAUSE WILL BE DIFFICULT IF NOT IMPOSSIBLE TO DETERMINE. DUE TO THE REPORTED INCIDENT, MEDICAL INTERVENTION AND IN AN ABUNDANCE OF CAUTION, THIS MEDWATCH IS BEING FILED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED, "THE OPERATING ROOM (OR) TOWELS HAVING LINT/FIBERS & IT SPREAD ALL OVER TO THE SURGICAL GLOVES, INSTRUMENTS, DRAPES & POTENTIALLY ON THE PATIENT. THIS IS HAPPENING IN THE MIDDLE OF THE CASE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    580291 MEDLINE TOWEL,OR,DSP,ST,BLUE,STD,4/PK FRL MEDLINE INDUSTRIES INC. MDT2168284 10080196282739

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention