BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LMA FLEXIBLE, REU, SIZE 2.5

    MDR report key: 5053033 · Received September 3, 2015

    Report

    Report Number
    9681900-2015-00050
    Event Type
    Malfunction
    Date Received
    September 3, 2015
    Date of Event
    August 26, 2015
    Report Date
    August 27, 2015
    Manufacturer
    THE LARYNGEAL MASK COMPANY
    Product Code
    BTR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED AND THERE WERE NO ISSUES FOUND THAT COULD HAVE CONTRIBUTED TO THE REPORTED FAILURE. ALL PROCESSES WERE EXECUTED ACCORDING TO THE STANDARD OPERATING METHODS. A SAMPLE WAS RECEIVED AND OBSERVED TO HAVE A CLEAR AIRWAY TUBE. THE SAMPLE WAS IMMERSED INTO WATER AND THE FAILURE LOCATION WAS IDENTIFIED. UNDER CLOSER OBSERVATION THERE WAS A CUT ON THE SURFACE OF THE CUFF. THE CUT WAS CONSISTENT WITH AN OBJECT THAT HAS SHARP EDGES THAT WAS IN CONTACT WITH THE DEVICE. THE DEVICE WAS ALSO TESTED BY BEING INFLATED WITH AIR THROUGH A SYRINGE. THE DEVICE WAS UNABLE TO HOLD AIR THEREFORE, THE REPORTED FAILURE WAS CONFIRMED. THE REPORTED COMPLAINT WAS CONFIRMED THROUGH VISUAL AND FUNCTIONAL INSPECTION. THE REPORTED FAILURE OCCURRED AFTER 2-3 USES AND SUSPECTED TO BE DUE TO THE DEVICE BEING PUNCTURED INADVERTENTLY WHILE BEING HANDLED. CUSTOMER IS REMINDED THAT THE LMA REUSABLE AIRWAY DEVICE SHOULD BE HANDLED WITH CARE. OTHER REMARKS: THE DEVICE SHOULD NOT BE IN CLOSE CONTACT WITH OBJECTS THAT HAVE SHARP OR HARD EDGES OTHERWISE THIS WILL HAVE AN ADVERSE IMPACT AND IRREPARABLE DAMAGE ON THE SILICONE MATERIAL OF THE CUFF.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE SAMPLE WAS NOT RETURNED FOR EVALUATION AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS:THE CUSTOMER ALLEGES THE DEVICE WAS LEAKING DURING USE.THERE WAS NO REPORTED PATIENT HARM.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: THE CUSTOMER ALLEGES THE DEVICE WAS LEAKING DURING USE. THERE WAS NO REPORTED PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    584516 LMA FLEXIBLE, REU, SIZE 2.5 LARYNGEAL MASK AIRWAY BTR THE LARYNGEAL MASK COMPANY

    Patients

    Seq Age Sex Outcome Treatment
    1