BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LMA PROSEAL, REU, SIZE 4 (150040)

    MDR report key: 7597805 · Received June 13, 2018

    Report

    Report Number
    9681900-2018-00027
    Event Type
    Malfunction
    Date Received
    June 13, 2018
    Date of Event
    May 24, 2018
    Report Date
    May 25, 2018
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    CAE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE SAMPLE WAS RETURNED FOR EVALUATION. A VISUAL EXAM WAS PERFORMED AND NO PHYSICAL DAMAGE WAS OBSERVED. THE DEVICE COULD BE INFLATED AND DEFLATED WITH THE CHECK VALVE NORMALLY. IT WAS OBSERVED THAT THE DEFLATION WAS SLIGHTLY SLUGGISH WITH DEFLATED WITH THE RED PLUG OPEN; HOWEVER, WITH A SLIGHT PINCH ON THE SIDES ON THE RED PLUG THE DEFLATION IMPROVED. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND THERE WERE NO ISSUES FOUND THAT COULD RELATE TO THE REPORTED COMPLAINT. BASED ON THE INVESTIGATION PERFORMED, THE REPORTED COMPLAINT COULD NOT BE CONFIRMED. THE DEVICE WAS FUNCTIONAL AND COULD BE INFLATED AND DEFLATED USING THE CHECK VALVE. THE DEFLATION COULD IMPROVE 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.

    Description of Event or Problem · 0

    CUSTOMER COMPLAINT ALLEGES THE NEW DEVICE WOULD INFLATE BUT NOT DEFLATE PRIOR TO INITAL STERILIZATION. NO PATIENT INVOLVEMENT REPORTED WITH THIS EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    CUSTOMER COMPLAINT ALLEGES THE NEW DEVICE WOULD INFLATE BUT NOT DEFLATE PRIOR TO INITAL STERILIZATION. NO PATIENT INVOLVEMENT REPORTED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    440021 LMA PROSEAL, REU, SIZE 4 (150040) LMA PROSEAL CAE TELEFLEX MEDICAL SN:8VRAT5EN

    Patients

    Seq Age Sex Outcome Treatment
    1