BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTEX CRICOTHYROIDOTOMY

    MDR report key: 15409666 · Received September 13, 2022

    Report

    Report Number
    3012307300-2022-18871
    Event Type
    Malfunction
    Date Received
    September 13, 2022
    Date of Event
    January 1, 1901
    Report Date
    September 13, 2022
    Manufacturer
    SMITHS MEDICAL INTERNATIONAL, LTD.
    Product Code
    BWC
    UDI-DI
    15019315010989
    PMA / PMN Number
    K050166
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ONE SAMPLE WAS RECEIVED AT THE INVESTIGATION SITE IN ITS ORIGINAL PACKAGING. EXPIRY DATES ON LABELS VERSUS EXPIRY DATES IN SYSTEM VERSUS EXPIRY DATES IN PURCHASE ORDER WERE COMPARED AND IT WAS FOUND THAT THERE IS MISMATCH. EXPIRY DATES ON LABELS ARE CORRECT BUT EXPIRY DATES IN THE SYSTEM ARE INCORRECT. ROOT CAUSE RELATED TO QUALITY CONTROL. A REVIEW OF THE DEVICE HISTORY RECORDS (DHR) SHOWS THERE WERE NO OBSERVATIONS RECORDED DURING MANUFACTURE TO SUGGEST AN ISSUE OF THIS NATURE WOULD OCCUR WITH THIS LOT OF PRODUCT. ALL EXPIRY DATES WITHIN DHRS ARE CORRECT. NO INFORMATION HAS BEEN RECEIVED TO DATE. THIS REMEDIATION MDR WAS GENERATED UNDER PROTOCOL (B)(4), AS A RESULT OF WARNING LETTER CMS# (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SOME OF THE PEREMPTION DATES OF BATCHES THAT ARE NOT MATCHING WITH THE BOXES OF GOODS RECEIVED. NO PATIENT INJURY OR INVOLVEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1951300 PORTEX CRICOTHYROIDOTOMY NEEDLE, EMERGENCY AIRWAY BWC SMITHS MEDICAL INTERNATIONAL, LTD. 100/465/060 3820782 15019315010989

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown