BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RUSCH NASOPHARYNGEAL AIRWAY, LATEX FREE

    MDR report key: 11045409 · Received December 21, 2020

    Report

    Report Number
    8040412-2020-00264
    Event Type
    Malfunction
    Date Received
    December 21, 2020
    Date of Event
    November 4, 2020
    Report Date
    November 26, 2020
    Product Code
    BTQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE SAMPLE WAS RETURNED FOR EVALUATION. A VISUAL EXAM WAS PERFORMED AND IT WAS OBSERVED THAT THE SAMPLE CONTAINED VAPORS INSIDE THE PACKAGING. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND NO RELEVANT FINDINGS WERE IDENTIFIED. A CAPA WAS OPENED TO FURTHER ADDRESS THIS ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT: "INCIDENT OBSERVED AT THE OPERATING ROOM. WHILST SHE WAS PREPARING DEVICES BEFORE AN INTERVENTION, THE NURSE OBSERVED THAT THE DEVICE WAS WET INSIDE THE NON-OPENED STERILE PACKAGING". NO PATIENT INVOLVEMENT REPORTED. PRODUCT WAS REPLACED PRIOR TO PATIENT USE.

    Additional Manufacturer Narrative · 1

    QN#: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT: "INCIDENT OBSERVED AT THE OPERATING ROOM. WHILST SHE WAS PREPARING DEVICES BEFORE AN INTERVENTION, THE NURSE OBSERVED THAT THE DEVICE WAS WET INSIDE THE NON-OPENED STERILE PACKAGING". NO PATIENT INVOLVEMENT REPORTED. PRODUCT WAS REPLACED PRIOR TO PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1515698 RUSCH NASOPHARYNGEAL AIRWAY, LATEX FREE AIRWAY, NASAL BTQ KMA20H1247

    Patients

    Seq Age Sex Outcome Treatment
    1