BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LMA PROSEAL, REU, SIZE 5 (150050)

    MDR report key: 7215087 · Received January 24, 2018

    Report

    Report Number
    9681900-2018-00006
    Event Type
    Malfunction
    Date Received
    January 24, 2018
    Date of Event
    December 1, 2017
    Report Date
    January 5, 2017
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    CAE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE INVOLVED IN THIS COMPLAINT HAS NOT BEEN RECEIVED BY THE MANUFACTURER AT THE TIME OF THIS REPORT. THE INVESTIGATION INTO THIS COMPLAINT IS STILL IN PROGRESS.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS RETURNED FOR EVALUATION. A VISUAL EXAM WAS PERFORMED AND IT WAS OBSERVED THAT THE AIRWAY TUBE WAS SLIGHTLY YELLOWISH DUE TO MULTIPLE USES. THERE WAS NO PHYSICAL DAMAGE FOUND ON THE OUTER PROFILE OF THE DEVICE. THE DEVICE COULD BE INFLATED AND DEFLATED NORMALLY WITH THE CHECK VALVE. THE CUFF COULD NOT BE DEFLATED WHEN THE RED PLUG WAS OPENED. A DEVICE HISTORY RECORD WAS PERFORMED AND THERE WERE NO ISSUES FOUND THAT COULD RELATE TO THE REPORTED COMPLAINT. THE COMPLAINT HAS BEEN CONFIRMED. THE OPENING OF THE RED PLUG WAS BLOCKED BY THE VALVE HENCE THE CUFF COULD NOT BE DEFLATED EVEN WHEN THE RED PLUG WAS OPENED. THE MOST PROBABLE ROOT CAUSE COULD HAVE BEEN THAT EXCESSIVE FORCE WAS APPLIED TO THE VALVE INSIDE THE BLUE INFLATION BALLOON WHEN INFLATING OR DEFLATING THE DEVICE OR OVER A PROLONGED PERIOD/MULTIPLE USES, THE VALVE HAD GONE FURTHER INTO THE TUBING WHICH RESULTED IN THE RED PLUG OPENING BEING BLOCKED BY THE VALVE. THE DEVICE IS STILL FUNCTIONAL, HOWEVER, AND CAN STILL BE INFLATED AND DEFLATED NORMALLY USING THE CHECK VALVE.

    Description of Event or Problem · 1

    CUSTOMER COMPLAINT ALLEGES "LATER THEY FOUND FAILURE ON ONE CUFF-VALVE. THEY COULD GET AIR INSIDE THE CUFF BUT NOT OUT AGAIN. EVEN IF THEY OPENED THE VALVE AND TRIED TO PULL AIR OUT WITH A SYRINGE THE VALVE WAS ONLY WORKING ONE WAY TO GET AIR INSIDE, NOT BACK OUT. " ALLEGED EVENT REPORTED AS OCCURRED PRIOR TO A PATIENT USE DURING INSPECTION/FUNCTIONAL TESTING . THERE WAS NO REPORT OF PATIENT IMPACT OR CONSEQUENCE.

    Description of Event or Problem · 1

    CUSTOMER COMPLAINT ALLEGES "LATER THEY FOUND FAILURE ON ONE CUFF-VALVE. THEY COULD GET AIR INSIDE THE CUFF BUT NOT OUT AGAIN. EVEN IF THEY OPENED THE VALVE AND TRIED TO PULL AIR OUT WITH A SYRINGE THE VALVE WAS ONLY WORKING ONE WAY TO GET AIR INSIDE, NOT BACK OUT. " ALLEGED EVENT REPORTED AS OCCURRED PRIOR TO A PATIENT USE DURING INSPECTION/FUNCTIONAL TESTING . THERE WAS NO REPORT OF PATIENT IMPACT OR CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    59352 LMA PROSEAL, REU, SIZE 5 (150050) AIRWAY,OROPHARYNGEAL,ANESTHESIOLOGY CAE TELEFLEX MEDICAL MFAACB

    Patients

    Seq Age Sex Outcome Treatment
    1