BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PORTEX MINI-TRACH II SELDINGER KIT

    MDR report key: 8502124 · Received April 10, 2019

    Report

    Report Number
    3012307300-2019-01880
    Event Type
    Injury
    Date Received
    April 10, 2019
    Date of Event
    March 8, 2019
    Report Date
    July 10, 2019
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    JOH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE AFFECTED COMPONENT IS SUPPLIED TO CUMBERNAULD BY SMITHS MEDICAL FRAUREUTH. THE SAMPLE FOR THIS COMPLAINT WAS SENT TO THE MANUFACTURING SITE, (B)(4) WHO CARRIED OUT A FULL INVESTIGATION INTO THE REPORTED ISSUE BASED ON THE SAMPLE WHICH WAS RETURNED. THE CANNULA CAP OF THE TRACHEOSTOMY COULD HAVE BEEN DEFORMED DUE TO HIGH TEMPERATURES (I.E. DURING SEALING OF FINISHED GOOD KIT (100/461/000) IN CUMBERNAULD). THE REPORTED CUSTOMER COMPLAINT HAS BEEN CONFIRMED, AND THE PROBLEM SOURCE HAS BEEN DETERMINED TO BE A RESULT OF MANUFACTURING.

    Additional Manufacturer Narrative · 1

    REPORT SOURCE: (B)(6).

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED THAT WHEN USING A SMITHS MEDICAL PORTEX MINI-TRACH II SELDINGER KIT AT THE END OF A PROCEDURE, THE USER ATTEMPTED TO TIGHTEN THE CAP OF THE TRACHEAL CANNULA, BUT FOUND THAT "THE PROTUBERANCES INSIDE THE CAP WERE CRUSHED". SUBSEQUENTLY, THEY "REPLACED IT WITH A NEW PRODUCT AND REWORKED THE PROCEDURE". NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293489 PORTEX MINI-TRACH II SELDINGER KIT TUBE TRACHEOSTOMY AND TUBE CUFF JOH SMITHS MEDICAL ASD, INC. 3665058

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention