BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RUSCH ADJ FLANGE NON LATEX NASA

    MDR report key: 11858651 · Received May 20, 2021

    Report

    Report Number
    8040412-2021-00146
    Event Type
    Malfunction
    Date Received
    May 20, 2021
    Date of Event
    May 5, 2021
    Report Date
    May 5, 2021
    Product Code
    BTQ
    UDI-DI
    14026704336170
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    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. THE MANUFACTURING SITE REPORTS THAT "THE FITR TEST RESULT ON VAPOR ANALYSIS ON THE SAME COMPLAINT NATURE, THE VAPOR IS IDENTIFIED AS CALCIUM NITRATE. IT IS PART OF MATERIAL USED DURING PRODUCTION PROCESS OF MAKING THIS PRODUCT. FROM THE ANALYSIS, DUE TO POROSITY OF SYNTHETIC MATERIAL, BASED MATERIAL FOR THIS PRODUCT THE REPORTED DEFECT COULD BE OCCURRED AND WITHOUT CHLORINATION LEAD TO HOLDING CALCIUM NITRATE IN LAYERS, IT WILL BE VAPORIZED AT LOWER TEMPERATURE (<20 CELSIUS) AND HIGH RELATIVE HUMIDITY 90%." THE MANUFACTURER ALSO REPORTS THAT "THE CHEMICAL IS COMMON PART OF THESE PRODUCTS AND THEIR BIOCOMPATIBILITY WAS TESTED AND CONFIRMED. HOWEVER, IN THE ABSENCE OF ACTUAL SAMPLE BEING RETURNED AND LIMITED INFORMATION AVAILABLE FOR THIS COMPLAINT, FURTHER INVESTIGATION COULD NOT BE CONDUCTED." A CAPA WAS OPENED TO FURTHER ADDRESS THIS ISSUE RELATED TO VAPOR INSIDE THE PACKAGING.

    Description of Event or Problem · 0

    IT WAS REPORTED "I SPOKE WITH A STAFF MEMBER WHO DESCRIBED ONE OF THE 18542032 UNITS AS HAVING CONDENSATION WITHIN THE PACKAGING". NO PATIENT INVOLVEMENT REPORTED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED "I SPOKE WITH A STAFF MEMBER WHO DESCRIBED ONE OF THE 18542032 UNITS AS HAVING CONDENSATION WITHIN THE PACKAGING". NO PATIENT INVOLVEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    752315 RUSCH ADJ FLANGE NON LATEX NASA AIRWAY, NASOPHARYNGEAL BTQ IPN042923 N/A 14026704336170

    Patients

    Seq Age Sex Outcome Treatment
    1