BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLUE RHINO G2-MULTI PERCUTANEOUS TRACHEOSTOMY INTRODUCER TRAY

    MDR report key: 14362217 · Received May 11, 2022

    Report

    Report Number
    1820334-2022-00712
    Event Type
    Malfunction
    Date Received
    May 11, 2022
    Report Date
    August 2, 2022
    Manufacturer
    COOK INC
    Product Code
    JOH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: REPORTED TO HAVE OCCURRED WITHIN THE LAST 3-4 MONTHS. PMA/510(K) #: K193133. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.

    Additional Manufacturer Narrative · 0

    CORRECTION: UPON FURTHER REVIEW OF THE FILE AND DISCUSSION WITH RR LEADERSHIP, QE LEADERSHIP, CLINICAL REVIEWERS, AND MEDICAL ADVISOR, IT WAS DETERMINED THAT CHANGING FROM A PERCUTANEOUS TRACHEOSTOMY PROCEDURE TO AN OPEN TRACHEOSTOMY PROCEDURE IN THE OPERATING ROOM DOES NOT CONSTITUTE MEDICAL INTERVENTION TO PRECLUDE PERMANENT IMPAIRMENT OR DEATH AS THE CHANGE IN APPROACH DOES NOT INCREASE RISK TO THE PATIENT OR CHANGE THE PATIENT'S STATUS. THEREFORE, THIS EVENT IS NO LONGER CONSIDERED A SERIOUS INJURY PER 21 CFR PART 803.3. ADDITIONALLY, A REVIEW OF REPORTING SOFTWARE REVEALED THAT NO SIMILAR EVENTS WHERE "UNABLE TO TRACK TUBE INTO TARGET SITE" RESULTED IN HEIGHTENED PATIENT RISK. AS THERE ARE NO RECORDED INCIDENCES OF SERIOUS INJURY DUE TO THE REPORTED FAILURE MODE AND IT IS NOT LIKELY THAT SERIOUS INJURY WOULD RESULT IF THE EVENT WERE TO RECUR THE EVENT IS NOT REPORTABLE PER 21CFR PART 803.50.

    Description of Event or Problem · 0

    IT WAS REPORTED THE TRACHEOSTOMY TUBE IN A BLUE RHINO G2-MULTI PERCUTANEOUS TRACHEOSTOMY INTRODUCER TRAY WAS DIFFICULT TO ADVANCE DURING A PERCUTANEOUS TRACHEOSTOMY PROCEDURE. DURING THE PROCEDURE, A VERTICAL INCISION WAS MADE AND DISSECTED DOWN UNTIL RINGS WERE PALPABLE. A BRONCHOSCOPE WAS INSERTED AND THE ENDOTRACHEAL TUBE (ETT) WAS SLOWLY BACKED OUT UNTIL DIGITAL PALPATION AND/OR LIGHT NOTED AT POINT OF 2ND/3RD TRACHEAL RINGS. THE NEEDLE AND CATHETER WAS INSERTED UNDER DIRECT VISUALIZATION. THE WIRE WATCHED TO PASS DISTALLY. THE SMALL DILATOR WAS USED THREE TIMES. THE LARGE DILATOR WITH WHITE GUIDING CATHETER WAS PLACED OVER THE WIRE GUIDE WITH BLACK LINE ENTERING TRACHEA THREE TIMES. UPON PLACEMENT OF THE TRACHEOSTOMY TUBE, IT WAS DIFFICULT TO ADVANCE AND WOULD NOT EASILY ENTER THE TRACHEA. THE BEDSIDE INTENSIVE CARE UNIT (ICU) PERCUTANEOUS TRACHEOSTOMY PROCEDURE WAS NOT ABLE TO BE COMPLETED. THE ETT HAD TO BE REINSERTED INTO THE TRACHEA AND THE PATIENT WAS TAKEN TO THE OPERATING ROOM FOR A FORMAL OPEN TRACHEOSTOMY TUBE PLACEMENT. THE PHYSICIAN STATED THAT THE TRACHEOSTOMY TUBE THAT IS CURRENTLY SUPPLIED WITH THE BLUE RHINO (7.5 SHILEY FLEXIBLE ADULT TRACH TUBE) IS TOO SOFT COMPARED TO THE PREVIOUS VERSION. NO ADVERSE EFFECTS TO THE PATIENT HAVE BEEN REPORTED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1790977 BLUE RHINO G2-MULTI PERCUTANEOUS TRACHEOSTOMY INTRODUCER TRAY JOH TUBE TRACHEOSTOMY AND TUBE CUFF JOH COOK INC N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention