BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    60-7070-106 TRNQT,DPSB,PLC BROWN

    MDR report key: 11913004 · Received June 1, 2021

    Report

    Report Number
    3032391-2021-00012
    Event Type
    Malfunction
    Date Received
    June 1, 2021
    Date of Event
    April 19, 2021
    Report Date
    June 1, 2021
    Manufacturer
    MEDLINE INDUSTRIES INC.
    Product Code
    KCY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED, "SEVERAL OF THE TOURNIQUETS RECEIVED ARE MISSING THE O-RING WHICH RESULTED IN A BIG ISSUE BECAUSE THE TOURNIQUET FAILED DURING THE PROCEDURE." EMAIL RECEIVED BY SURGICAL SERVICES MANAGER, SIERRA VIEW MEDICAL CENTER, WHO PROVIDED ADDITIONAL INFORMATION IN REGARDS TO THIS INCIDENT. REPORTER STATES, INCIDENT OCCURRED (B)(6) 2021, DURING A LEFT TOTAL KNEE ARTHROPLASTY PROCEDURE. REPORTER STATES, "FROM WHAT MY INVESTIGATION HAS LED TO IS THAT THE WRONG TOURNIQUETS WAS EITHER ORDERED OR SENT FROM MEDLINE." REPORTER CONFIRMS PATIENT WAS UNDER GENERAL ANESTHESIA AND STATES "THE TOURNIQUET FAILED AND LOST PRESSURE DURING THE CASE." REPORTER STATES, "THIS RESULTED IN DELAY OF PATIENT CARE AS WELL AS EXTENDED PROCEDURE TIME." REPORTER STATES, THE TOURNIQUET WAS REPLACED WITH ANOTHER MANUFACTURES BRAND TOURNIQUET. THE PATIENT IS REPORTEDLY DOING "OK." THE SAMPLE IS NOT AVAILABLE FOR RETURN AND EVALUATION, WHICH WILL MAKE DETERMINING A ROOT CAUSE DIFFICULT. 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, "SEVERAL OF THE TOURNIQUETS RECEIVED ARE MISSING THE O-RING WHICH RESULTED IN A BIG ISSUE BECAUSE THE TOURNIQUET FAILED DURING THE PROCEDURE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    813885 60-7070-106 TRNQT,DPSB,PLC BROWN KCY MEDLINE INDUSTRIES INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention