BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LMA UNIQUE SIZE 4

    MDR report key: 10355981 · Received August 3, 2020

    Report

    Report Number
    9681900-2020-00009
    Event Type
    Malfunction
    Date Received
    August 3, 2020
    Date of Event
    June 29, 2020
    Report Date
    July 16, 2020
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    CAE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    QN#(B)(4). COMPLAINT VERIFICATION TESTING COULD NOT BE PERFORMED AS IT WAS REPORTED THAT THE SAMPLE IS NOT AVAILABLE FOR RETURN. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND NO RELEVANT FINDINGS WERE IDENTIFIED. WITHOUT THE DEVICE TO EVALUATE THE COMPLAINT COULD NOT BE CONFIRMED AND THE PROBABLE CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE.

    Description of Event or Problem · 0

    CUSTOMER COMPLAINT REPORTED AS: "WHEN WE OPENED THE PACKAGING PRIOR TO USE IT ON THE PATIENT, DURING TEST, WE FOUND A PLASTIC FILAMENT IN THE TUBING OF THE DEVICE. IT COULD GO IN THE LUNGS SO THE DEVICE WAS REPLACED AND NOT USED. SO THERE WAS NO CLINICAL CONSEQUENCE."

    Additional Manufacturer Narrative · 1

    QN#20035850.

    Description of Event or Problem · 1

    CUSTOMER COMPLAINT REPORTED AS: "WHEN WE OPENED THE PACKAGING PRIOR TO USE IT ON THE PATIENT, DURING TEST, WE FOUND A PLASTIC FILAMENT IN THE TUBING OF THE DEVICE. IT COULD GO IN THE LUNGS SO THE DEVICE WAS REPLACED AND NOT USED. SO THERE WAS NO CLINICAL CONSEQUENCE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    820256 LMA UNIQUE SIZE 4 LMA UNIQUE CAE TELEFLEX MEDICAL IPN901801 PMBSQP

    Patients

    Seq Age Sex Outcome Treatment
    1