BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LMA PROSEAL, REU, SIZE 4

    MDR report key: 4943070 · Received July 27, 2015

    Report

    Report Number
    9681900-2015-00047
    Event Type
    Malfunction
    Date Received
    July 27, 2015
    Date of Event
    March 19, 2015
    Report Date
    July 3, 2015
    Manufacturer
    THE LARYNGEAL MASK COMPANY
    Product Code
    BTR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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. THE DEVICE WAS OBSERVED TO HAVE A BROKEN CONNECTOR (BROKEN INTO 2 PORTIONS WITH 1 PORTION STILL ATTACHED TO AIRWAY TUBE) AND THE AIRWAY TUBE WAS DISCOLORED. THE CONNECTOR WAS OBSERVED TO HAVE CRAZED LINES WHICH WERE SMOOTH TO TOUCH DURING THE INSPECTION. THE REPORTED DEFECT WAS CONFIRMED THROUGH VISUAL INSPECTION. DUE TO THE PROFILE OF THE CRAZED LINES ON THE BROKEN CONNECTOR, THE FAILURE WAS MOST LIKELY DUE TO A CHEMICAL THAT WAS IN CONTACT WITH THE DEVICE. THE STURDINESS OF THE POLYSULPHONE, THE MATERIAL THE CONNECTOR IS MADE OF, WAS IMPACTED. OTHER REMARKS: THE NON-COMPATIBLE DETERGENT, CONCENTRATED DETERGENT OR HIGH AUTOCLAVING TEMPERATURE COULD HAVE ACCELERATED THE DETERIORATION OF THE CONNECTOR. THE CONNECTOR MUST BE INSPECTED FOR CRAZING PRIOR TO USE. THERE IS ALSO A PREVIOUS STUDY CONFIRMING THAT IF THE LMA PROSEAL IS STERILIZED WITH LUBRICATED MEDICAL INSTRUMENTS, THE LUBRICANT WILL ACCELERATE DETERIORATION OF THE CONNECTOR. THE LMA PROSEAL SHOULD BE PROCESSED WITH A MILD DETERGENT SUCH AS ENDOZIME AND AUTOCLAVED (HOLD TIME) 10 MINUTES AT 134 DEGREES CELSIUS.

    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 15MM CONNECTOR SNAPPED DURING USE. THERE WAS NO REPORTED PATIENT HARM.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS:THE CUSTOMER ALLEGES THE 15MM CONNECTOR SNAPPED DURING USE.THERE WAS NO REPORTED PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    486909 LMA PROSEAL, REU, SIZE 4 LARYNGEAL MASK AIRWAY BTR THE LARYNGEAL MASK COMPANY

    Patients

    Seq Age Sex Outcome Treatment
    1