BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LMA SUPREME SIZE 5

    MDR report key: 10303532 · Received July 21, 2020

    Report

    Report Number
    9681900-2020-00007
    Event Type
    Malfunction
    Date Received
    July 21, 2020
    Date of Event
    July 1, 2020
    Report Date
    July 6, 2020
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    CAE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    QN#(B)(4). THE SAMPLE WAS RETURNED FOR EVALUATION. A VISUAL EXAM WAS PERFORMED AND IT WAS FOUND THERE WAS A TEAR ON THE PARTING LINE OF THE CUFF. A LEAK TEST WAS PERFORMED AND THE DEVICE WAS FOUND TO LEAK AT THE LOCATION OF THE TEAR. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND NO RELEVANT FINDINGS WERE IDENTIFIED. BASED ON THE INVESTIGATION PERFORMED, THE REPORTED COMPLAINT WAS CONFIRMED. A TEAR WAS FOUND ON THE PARTING LINE OF THE CUFF. LEAKING WAS FOUND AT THE LOCATION OF THE TEAR. THE ROOT CAUSE WAS FOUND TO BE MANUFACTURING RELATED. A NON-CONFORMANCE WAS OPENED TO ADDRESS THIS ISSUE.

    Description of Event or Problem · 0

    CUSTOMER COMPLAINT REPORTED AS: "BEFORE USE A LEAK - CUFF - WAS DISCOVERED. DEFECT WAS OBSERVED AFTER OPENING OF THE PACKAGE AND DURING LEAK TEST FIRST USAGE)".

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    CUSTOMER COMPLAINT REPORTED AS: "BEFORE USE A LEAK - CUFF - WAS DISCOVERED. DEFECT WAS OBSERVED AFTER OPENING OF THE PACKAGE AND DURING LEAK TEST FIRST USAGE)".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    764593 LMA SUPREME SIZE 5 LMA SUPREME CAE TELEFLEX MEDICAL IPN902076 PMAS5W

    Patients

    Seq Age Sex Outcome Treatment
    1