BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTEX EMERGENCY CRICOTHYROIDOTOMY KIT

    MDR report key: 15234245 · Received August 16, 2022

    Report

    Report Number
    3012307300-2022-15429
    Event Type
    Malfunction
    Date Received
    August 16, 2022
    Date of Event
    July 15, 2022
    Report Date
    September 29, 2022
    Manufacturer
    SMITHS MEDICAL INTERNATIONAL, LTD.
    Product Code
    BWC
    PMA / PMN Number
    K050166
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. UDI SECTION IS UNKNOWN, NO PRODUCT INFORMATION HAS BEEN PROVIDED TO DATE.

    Additional Manufacturer Narrative · 0

    OTHER, OTHER TEXT: NO LOT NUMBER WAS PROVIDED FOR DEVICE HISTORY RECORD REVIEW.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT IMMEDIATELY AFTER OPENING THE PACKAGE, THE CUSTOMER NOTICED THE RED COMPONENT (A STOPPER) WAS MISSING. NO PATIENT INJURY WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1237735 PORTEX EMERGENCY CRICOTHYROIDOTOMY KIT NEEDLE, EMERGENCY AIRWAY BWC SMITHS MEDICAL INTERNATIONAL, LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown