BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DBD-CATH LAB OHH

    MDR report key: 10211673 · Received June 30, 2020

    Report

    Report Number
    1423395-2020-00014
    Event Type
    Malfunction
    Date Received
    June 30, 2020
    Date of Event
    June 14, 2020
    Report Date
    June 30, 2020
    Manufacturer
    MEDLINE INDUSTRIES INC.
    Product Code
    OEQ
    UDI-DI
    10193489282443
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED LINT WAS FOUND INSIDE THE PATIENT DURING A CORONARY INTERVENTION PROCEDURE. ACCORDING TO THE CUSTOMER, THE CORONARY GUIDE WIRES HAD TO BE REMOVED AFTER CROSSING LESION AND POST BALLOON ANGIOPLASTY. IT WAS REPORTED NO SERIOUS INJURY OR FOLLOW-UP CARE RELATED TO THE PATIENT INCIDENT. NO ADDITIONAL INFORMATION WAS AVAILABLE RELATED TO THE EVENT. THE SAMPLE WAS RECEIVED FOR EVALUATION. IT IS RECOMMENDED TO USE A SEPARATE DEDICATED CONTAINER FOR FLUSH SOLUTION. DUE TO THE REPORTED NEED FOR MEDICAL INTERVENTION AND IN AN ABUNDANCE OF CAUTION, THIS IS A MDR REPORTABLE EVENT. IF ADDITIONAL INFORMATION BECOMES AVAILABLE A SUPPLEMENTAL MDR WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED LINT WAS FOUND INSIDE THE PATIENT DURING A CORONARY INTERVENTION PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    679547 DBD-CATH LAB OHH OEQ MEDLINE INDUSTRIES INC. 20CBI454 10193489282443

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention