BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LMA PROSEAL, REU, SIZE 3 (150030)

    MDR report key: 6908452 · Received October 2, 2017

    Report

    Report Number
    9681900-2017-00037
    Event Type
    Malfunction
    Date Received
    October 2, 2017
    Date of Event
    July 28, 2017
    Report Date
    September 15, 2017
    Manufacturer
    THE LARYNGEAL MASK COMPANY
    Product Code
    CAE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. THE RECORD CARD RETURNED WITH THE DEVICE INDICATES 17 USES. A VISUAL EXAM WAS PERFORMED AND IT WAS OBSERVED THAT THE AIRWAY OF THE TUBE WAS LIGHTLY DISCOLORED AND IT WAS VERIFIED THAT THE CUFF WOULD NOT HOLD AIR WHEN INFLATED. WHEN THE DEVICE WAS IMMERSED IN WATER, IT WAS OBSERVED THAT THERE WERE AIR BUBBLES COMING FROM THE CUFF. UPON CLOSER OBSERVATION, IT WAS FOUND THAT THERE WAS A CUT ON THE SURFACE OF THE CUFF. THE LENGTH OF THE CUT WAS APPROXIMATELY 1MM. A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED AND THERE WERE NO ISSUES FOUND THAT COULD RELATE TO THE REPORTED COMPLAINT. BASED ON THE INVESTIGATION PERFORMED, THE REPORTED COMPLAINT WAS CONFIRMED. IT WAS DETERMINED THAT THE DEVICE WAS PUNCTURED/CUT INADVERTENTLY DURING HANDLING BY THE CUSTOMER. PLACING, WASHING, OR AUTOCLAVING THE DEVICE WITH ITEMS THAT HAVE A HARD OR SHARP EDGE/POINT SHOULD BE AVOIDED AS IT WILL HAVE AN ADVERSE IMPACT TO THE SILICONE MATERIAL OF THE CUFF AND WILL PERMANENTLY DAMAGE IT.

    Description of Event or Problem · 1

    CUSTOMER COMPLAINT ALLEGES "A NURSE FOUND AN AIR LEAK FROM THE CUFF WHILE CONDUCTING INSPECTION BEFORE USING IT TO A PATIENT AT OPERATING ROOM." THERE WAS NO REPORT OF PATIENT HARM OR DELAY IN TREATMENT.

    Description of Event or Problem · 1

    CUSTOMER COMPLAINT ALLEGES " A NURSE FOUND AN AIR LEAK FROM THE CUFF WHILE CONDUCTING INSPECTION BEFORE USING IT TO A PATIENT AT OPERATING ROOM." THERE WAS NO REPORT OF PATIENT HARM OR DELAY IN TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    688897 LMA PROSEAL, REU, SIZE 3 (150030) AIRWAY,OROPHARYNGEAL,ANESTHESIOLOGY CAE THE LARYNGEAL MASK COMPANY 8WQADCLZ

    Patients

    Seq Age Sex Outcome Treatment
    1