BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KIT,CATHETER,SUCTION,14 FR,WHISTL,2 GLV

    MDR report key: 10575521 · Received September 23, 2020

    Report

    Report Number
    1417592-2020-00103
    Event Type
    Malfunction
    Date Received
    September 23, 2020
    Date of Event
    January 1, 2020
    Report Date
    September 23, 2020
    Manufacturer
    MEDLINE INDUSTRIES INC.
    Product Code
    OFR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT WITH AN UNKNOWN NUMBER OF PATIENTS, WHEN EXTRACTING THE TUBE, THE GREEN ATTACHMENT AT END OF THE TUBE WOULD JUST FALL OFF REQUIRING THE CATHETER TO BE PULLED OUT OF THE TRACH. THE FACILITY STATED THAT THEY WERE ABLE TO MANUALLY RETRIEVE THE ENTIRE TUBE, PUT THE DEVICE TO THE SIDE, GET ANOTHER CATHETER AND COMPLETE THE PATIENT'S PROCEDURES WITHOUT FURTHER INCIDENT. THERE WAS NO REPORT OF ANY ADVERSE PATIENT CONSEQUENCE AND NO EFFECT ON THE PATIENT'S STABILITY, AS A RESULT OF THE INCIDENT. THERE WERE NO SIGNS OF MISHANDLING OR PRODUCT/PACKAGING DAMAGE NOTED PRIOR TO USE. THERE WAS NO INADVERTENT FORCE APPLIED TO OR AGAINST THE CATHETER DURING USE. THERE WAS NO IMPACT TO THE PATIENT'S STABILITY OR OXYGEN LEVEL AS A RESULT OF THE INCIDENT. THERE WAS NO SERIOUS INJURY IDENTIFIED OR FOLLOW UP CARE REQUIRED RELATED TO THE EVENT. THE CATHETER WAS REPLACED AND THE PROCEDURE WAS COMPLETED AS PLANNED. THERE WERE NO COMPLICATIONS NOTED WITH ANY PATIENT DURING OR AFTER THE PROCEDURE. ONE OF THE ACTUAL DEVICES WAS RETURNED TO THE MANUFACTURER FOR EVALUATION, HOWEVER THE EVALUATION IN STILL IN PROCESS. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. DUE TO THE REPORTED INCIDENT 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

    WHEN EXTRACTING THE SUCTION CATHETER, FROM AN UNKNOWN NUMBER OF PATIENTS, THE GREEN ATTACHMENT ON THE SUCTION CATHETER DISCONNECTED FROM THE TUBING REQUIRING THE TUBING TO BE MANUALLY REMOVED FROM THE PATIENT TRACH TUBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1041857 KIT,CATHETER,SUCTION,14 FR,WHISTL,2 GLV OFR MEDLINE INDUSTRIES INC. 6052004012

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention