BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LMA FLEXIBLE, REU, SIZE 2.5

    MDR report key: 5772942 · Received July 6, 2016

    Report

    Report Number
    9681900-2016-00027
    Event Type
    Malfunction
    Date Received
    July 6, 2016
    Date of Event
    June 4, 2016
    Report Date
    July 5, 2016
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    CAE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    QN#(B)(4). CORRECTION: BRAND NAME - LMA FLEXIBLE, REU, SIZE 2.5. CATALOG# - 21125. DEVICE IS LABELED FOR SINGLE USE. USAGE OF DEVICE - INITIAL USE OF DEVICE. 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 ROOT CAUSE OF THE REPORTED DEFECT WAS UNABLE TO BE DETERMINED AS THE DEFECTIVE SAMPLE WAS NEVER RECEIVED FOR INVESTIGATION. HOWEVER, FROM THE PHOTO THAT WAS PROVIDED THE SMALL ELLIPTICAL FRAGMENT APPEARED TO BE THE EXCESS MATERIAL FROM THE APERTURE BAR OF THE CUFF. RELEVANT OPERATORS WERE MADE AWARE OF THE REPORTED DEFECT AND WERE INSTRUCTED TO BE MORE ATTENTIVE DURING PRODUCTION. THERE WILL BE CONTINUED TRENDING OF THE REPORTED DEFECT.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: THE CUSTOMER ALLEGES A SMALL ELLIPTICAL FRAGMENT OF SILICONE WAS FOUND WITHIN THE LUMEN DURING USE. THERE WAS NO PATIENT HARM REPORTED.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: THE CUSTOMER ALLEGES A SMALL ELLIPTICAL FRAGMENT OF SILICONE WAS FOUND WITHIN THE LUMEN DURING USE. THERE WAS NO PATIENT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    426185 LMA FLEXIBLE, REU, SIZE 2.5 LARYNGEAL MASK AIRWAY CAE TELEFLEX MEDICAL KDA2JD

    Patients

    Seq Age Sex Outcome Treatment
    1