BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARDEX NASOPHARYNGEAL AIRWAY

    MDR report key: 12615283 · Received October 12, 2021

    Report

    Report Number
    1018233-2021-06332
    Event Type
    Malfunction
    Date Received
    October 12, 2021
    Date of Event
    September 21, 2021
    Report Date
    February 9, 2022
    Manufacturer
    C.R. BARD, INC. (COVINGTON) -1018233
    Product Code
    BTQ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT WAS INCONCLUSIVE BECAUSE NO SAMPLE WAS RETURNED. A POTENTIAL ROOT CAUSE FOR THIS FAILURE COULD BE ¿FLANGE DIAMETER SMALL¿. IT IS UNKNOWN WHETHER THE DEVICE HAD MET RELEVANT SPECIFICATIONS. THE PRODUCT WAS USED FOR TREATMENT PURPOSES. IT WAS UNKNOWN WHETHER THE PRODUCT HAD CAUSED THE REPORTED FAILURE. THE DHR REVIEW COULD NOT BE PERFORMED WITHOUT A LOT NUMBER. A LABELING REVIEW WAS NOT PERFORMED BECAUSE LABELLING COULD NOT HAVE PREVENTED THE REPORTED FAILURE. H11: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BARD. H3 OTHER TEXT : THE DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT NASOPHARYNGEAL AIRWAYS WERE TOO SOFT AND THE CUSTOMER WOULD PREFER TO USE A SOME OTHER BRAND , AS THESE NASOPHARYNGEAL AIRWAYS SEEMED TO HAVE BECOME LESS RIGID RECENTLY. STATED THAT THERE WERE TOO MUCH RESISTANCE AND THEY COLLAPSED WHEN ATTEMPTING TO INSERT INTO THE NASAL PASSAGES.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT NASOPHARYNGEAL AIRWAYS WERE TOO SOFT AND THE CUSTOMER WOULD PREFER TO USE A SOME OTHER BRAND , AS THESE NASOPHARYNGEAL AIRWAYS SEEMED TO HAVE BECOME LESS RIGID RECENTLY. STATED THAT THERE WERE TOO MUCH RESISTANCE AND THEY COLLAPSED WHEN ATTEMPTING TO INSERT INTO THE NASAL PASSAGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1517858 BARDEX NASOPHARYNGEAL AIRWAY NASOPHARYNGEAL AIRWAY BTQ C.R. BARD, INC. (COVINGTON) -1018233 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other