BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LMA PROSEAL, REU, SIZE 4 (150040)

    MDR report key: 8024362 · Received October 31, 2018

    Report

    Report Number
    9681900-2018-00037
    Event Type
    Malfunction
    Date Received
    October 31, 2018
    Date of Event
    September 3, 2018
    Report Date
    October 29, 2018
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    CAE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE SAMPLE WAS RETURNED FOR EVALUATION. A VISUAL EXAM WAS PERFORMED AND THERE WAS NO DAMAGE OBSERVED. THE DEVICE WAS INFLATED AND DEFLATED WITH THE CHECK VALVE NORMALLY. IT WAS OBSERVED THAT THE DEFLATION WAS SLIGHTLY SLUGGISH WHEN DEFLATED WITH THE RED PLUG OPEN; HOWEVER, WITH A SLIGHT PINCH ON THE SIDES OF THE RED PLUG THE DEFLATION IMPROVED. 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, IT WAS FOUND THAT THE DEVICE WAS FULLY FUNCTIONAL, AND COULD BE INFLATED AND DEFLATED WITH THE CHECK VALVE NORMALLY. THE DEFLATION COULD BE IMPROVED WITH A SLIGHT PINCH ON THE SIDES OF THE RED PLUG. THIS COULD BE DUE TO INEVITABLE EXPANSION AND CONTRACTION OF THE COMPONENTS MATERIAL DURING LOGISTICS MOVEMENT OVER TIME. TRENDING OF THIS INCIDENT WILL BE CLOSELY MONITORED.

    Description of Event or Problem · 0

    CUSTOMER COMPLAINT ALLEGES "THE FACILITY REPORTS THAT SMOOTH AIR DEFLATION THROUGH THE RED PLUG WAS UNATTAINABLE AT THE INITIAL CLINICAL USE." ISSUE REPORTED OCCURRED DURING FUNCTIONAL TESTING PRIOR TO A PATIENT USE. PATIENT CONDITION REPORTED AS FINE.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    CUSTOMER COMPLAINT ALLEGES "THE FACILITY REPORTS THAT SMOOTH AIR DEFLATION THROUGH THE RED PLUG WAS UNATTAINABLE AT THE INITIAL CLINICAL USE." ISSUE REPORTED OCCURRED DURING FUNCTIONAL TESTING PRIOR TO A PATIENT USE. PATIENT CONDITION REPORTED AS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    866542 LMA PROSEAL, REU, SIZE 4 (150040) AIRWAY,OROPHARYNGEAL,ANESTHESIOLOGY CAE TELEFLEX MEDICAL SN:8VTAAQD3

    Patients

    Seq Age Sex Outcome Treatment
    1 NONE REPORTED.| NONE REPORTED.