BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RUSCH NASOPHARYNGEAL AIRWAY, LATEX FREE

    MDR report key: 14827728 · Received June 27, 2022

    Report

    Report Number
    8040412-2022-00162
    Event Type
    Malfunction
    Date Received
    June 27, 2022
    Date of Event
    May 24, 2022
    Report Date
    May 30, 2022
    Manufacturer
    TELEFLEX MEDICAL SDN. BHD.
    Product Code
    BTQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    QN#: (B)(4).

    Additional Manufacturer Narrative · 0

    (B)(4). THE ACTUAL SAMPLE WAS NOT RETURNED; HOWEVER, THE CUSTOMER PROVIDED A PHOTO FOR ANALYSIS. BASED ON THE EVALUATION OF THE PHOTO, THE COMPLAINT WAS CONFIRMED. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND NO RELEVANT FINDINGS WERE IDENTIFIED. THE MANUFACTURING SITE REPORTS A CAPA WAS OPENED TO FURTHER ADDRESS THIS ISSUE. THE STERILE LOT FOR THIS COMPLAINT IS 20G17. THIS INDICATES THE PRODUCT WAS PRODUCED PRIOR TO THE CAPA IMPLEMENTATION. THEREFORE, ALL THE ROOT CAUSE ANALYSIS AND IMPLEMENTATION OF CORRECTIVE ACTIONS REGARDING ON THIS DEFECT WILL BE MANAGED THROUGH A NON-CONFORMANCE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT "THERE WAS HUMIDITY INSIDE THE SEALED DEVICE". NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT "THERE WAS HUMIDITY INSIDE THE SEALED DEVICE". NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1071152 RUSCH NASOPHARYNGEAL AIRWAY, LATEX FREE AIRWAY, NASAL BTQ TELEFLEX MEDICAL SDN. BHD. IPN042909 20G17

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown