BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LMA FLEXIBLE, REU, SIZE 2.5 (110025)

    MDR report key: 6327137 · Received February 13, 2017

    Report

    Report Number
    9681900-2017-00007
    Event Type
    Malfunction
    Date Received
    February 13, 2017
    Date of Event
    January 3, 2017
    Report Date
    January 18, 2017
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    CAE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED FOR EVALUATION. THE SERIAL NUMBER WAS REPORTED AS (B)(4); HOWEVER, THE LOT NUMBER OF THE SAMPLE RECEIVED IS ASRD99144011. THE RETURNED DEVICE WAS COMPARED TO A RETAINED SAMPLE AT THE INVESTIGATION LAB. BOTH THE CONNECTOR SHAPE AND THE PRINT ON THE AIRWAY TUBE SURFACE WERE DIFFERENT FROM WHAT A TYPICAL LMA FLEXIBLE SHOULD BE LIKE FROM 2002 TO PRESENT. BASED ON THE SERIAL NUMBER OF THE RETURNED DEVICE (ASRD99144011), IT WAS DISCOVERED THAT IT WAS MANUFACTURED IN 1999. NO ORIGINAL PACKAGING AND NO USAGE RECORD CARD LISTING THE DATE OF FIRST USE WERE RETURNED. THE COMPLAINT DEVICE WAS ABLE TO DEFLATE AND INFLATE NORMALLY AND NO LEAKS WERE FOUND. BASED ON THE INVESTIGATION PERFORMED, THE REPORTED COMPLAINT COULD NOT BE CONFIRMED. NO LEAKS WERE FOUND WITH THE RETURNED DEVICE; HOWEVER, IT WAS MANUFACTURED IN 1999 AND OUT OF WARRANTY.

    Description of Event or Problem · 1

    CUSTOMER COMPLAINT ALLEGES THE DEVICE "SEEMS TO HAVE A SLIT WHERE THE AIRWAY TUBE CONNECTS WITH THE MASK, RESULTING IN A LEAK". ALLEGED DEFECT DETECTED DURING PRE-TESTING. NO REPORT OF PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    CUSTOMER COMPLAINT ALLEGES THE DEVICE "SEEMS TO HAVE A SLIT WHERE THE AIRWAY TUBE CONNECTS WITH THE MASK, RESULTING IN A LEAK". ALLEGED DEFECT DETECTED DURING PRE-TESTING. NO REPORT OF PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    108170 LMA FLEXIBLE, REU, SIZE 2.5 (110025) AIRWAY,OROPHARYNGEAL,ANESTHESIOLOGY CAE TELEFLEX MEDICAL SN 9JRAA4PH

    Patients

    Seq Age Sex Outcome Treatment
    1