BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTEX EMERGENCY CRICOTHYROIDOTOMY KIT

    MDR report key: 18573118 · Received January 24, 2024

    Report

    Report Number
    3011237704-2024-00024
    Event Type
    Malfunction
    Date Received
    January 24, 2024
    Date of Event
    December 1, 2023
    Report Date
    February 27, 2024
    Manufacturer
    SMITHS MEDICAL CZECH REPUBLIC A. S
    Product Code
    BWC
    PMA / PMN Number
    K050166
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    H6 - EVALUATION CODES: UPDATED. DEVICE EVALUATION: THE INVESTIGATION OF THE COMPLAINT WAS LIMITED BECAUSE NO SAMPLE WAS RETURNED. CUSTOMER IS CLAIMING THAT THE VALIDITY PERIOD ON THE PACKAGING IS DIFFERENT THAN PERIOD OF TIME IN THE PRODUCT INSTRUCTIONS. THE INSTRUCTION FOR USE MOST RECENT REVISION WAS CHECKED. THERE IS MENTIONED MAXIMUM RECOMMENDED PERIOD OF USE EQUAL TO 48 HOURS. THIS INFORMATION IS NOT RELATED TO THE EXPIRATION DATE. THE EXPIRATION DATE IS DETERMINED BY THE STERILE NYLON SUTURE NO 0 (3.5) WHICH IS DEFINED IN THE MANUFACTURE PROCEDURE. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) SHOWS THERE WERE NO OBSERVATIONS OR NONCONFORMITIES RECORDED DURING MANUFACTURE TO SUGGEST AN ISSUE OF THIS NATURE WOULD OCCUR WITH THIS LOT OF PRODUCTS. NO FINDINGS WERE OBSERVED. THERE WAS THE CORRECT EXPIRY DATE USED, ACCORDING TO THE SUTURE. UNFORTUNATELY WITHOUT THE SAMPLE OR MORE INFORMATION WE ARE UNABLE TO DETERMINE TRUE ROOT CAUSE OF THIS ISSUE. NO TREND OF CONFIRMED COMPLAINTS IN RELATION WITH THIS ISSUE WAS IDENTIFIED.

    Additional Manufacturer Narrative · 0

    D5: OPERATOR OF DEVICE, E1: FIRST AND LAST NAME IS UNKNOWN, NO INFORMATION HAS BEEN PROVIDED TO DATE. H3: OTHER; DEVICE NOT RETURNED TO MANUFACTURER. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN INSPECTION, "IT WAS FOUND THAT THE VALIDITY PERIOD ON THE PACKAGING OF THE EMERGENCY CRICOTHYROIDOTOMY KIT WAS INCONSISTENT WITH THE LIMITED PERIOD OF TIME IN THE PRODUCT INSTRUCTIONS, THUS THE COMPLIANCE OF THE PRODUCT WAS DOUBTFUL." THERE WAS NO PATIENT INVOLVEMENT, AND NO HARM/ADVERSE EVENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2478099 PORTEX EMERGENCY CRICOTHYROIDOTOMY KIT NEEDLE, EMERGENCY AIRWAY BWC SMITHS MEDICAL CZECH REPUBLIC A. S 100/465/060 4129409

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown