BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLUE RHINO G2-MULTI PERCUTANEOUS TRACHEOSTOMY INTRODUCER TRAY

    MDR report key: 14642308 · Received June 9, 2022

    Report

    Report Number
    1820334-2022-01018
    Event Type
    Malfunction
    Date Received
    June 9, 2022
    Date of Event
    May 2, 2022
    Report Date
    August 2, 2022
    Manufacturer
    COOK INC
    Product Code
    JOH
    UDI-DI
    00827002577169
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL REPORTER OCCUPATION: PATIENT CARE MANAGER. PMA/510K: 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

    UPON FURTHER INVESTIGATION, THIS EVENT IS NOT REPORTABLE. THERE IS NO INFORMATION CONFIRMING DEVICE MALFUNCTION OR SERIOUS INJURY. IT WAS DETERMINED THAT REMOVING THE KINKED WIRE GUIDE WITH THE ASSISTANCE OF BRONCHOSCOPE AND FORCEPS DOES NOT CONSTITUTE INTERVENTION TO PRECLUDE PERMANENT IMPAIRMENT OR DEATH. A REVIEW OF RISK DOCUMENTATION DOES NOT INDICATE THAT THIS EVENT IS LIKELY TO CAUSE SERIOUS INJURY IF IT WERE TO REOCCUR. A DETAILED SEARCH OF COMPLAINT HISTORY HAS REVEALED NO PREVIOUS EVENTS INVOLVING THE FAILURE MODE "KINKS" THAT HAS LED TO A SERIOUS INJURY. AS THERE ARE NO RECORDED INCIDENCES OF SERIOUS INJURY DUE TO THE COMPLAINT EVENT, AND IT IS NOT LIKELY THAT SERIOUS INJURY WOULD RESULT IF THE EVENT WERE TO RECUR, PER 21CFR PART 803.50 THE COMPLAINT EVENT IS CONSIDERED NOT REPORTABLE.

    Description of Event or Problem · 0

    A PATIENT OF UNSPECIFIED GENDER AND AGE UNDERWENT A TRACHEOSTOMY PROCEDURE WHERE A COOK BLUE RHINO G1-MULTI PERCUTANEOUS TRACHEOSTOMY INTRODUCER WAS USED. THE PATIENT DID NOT HAVE ANY ANATOMICAL ANOMALIES THAT WOULD HAVE MADE THE PROCEDURE DIFFICULT TO PERFORM. BRONCHOSCOPE GUIDANCE WAS USED DURING PLACEMENT. THE WIRE GUIDE WAS INSERTED THROUGH THE NEEDLE. THERE WAS NO DIFFICULTY ADVANCING THE WIRE GUIDE INTO THE TRACHEA. THE WIRE GUIDE WAS NOT WITHDRAWN AT THE SAME TIME THE DILATOR AND CATHETER WERE REMOVED. THE GUIDE WIRE WAS REPORTED TO HAVE "LOOPED BACK ON ITSELF AND WAS KINKING INSIDE THE TRACHEA." THE PROCEDURE WAS COMPLETED, BUT THE USE OF A BRONCHOSCOPE WITH FORCEPS WAS REQUIRED TO REMOVE THE WIRE. AN ESOPHAGOGASTRODUODENOSCOPY (EGD) EXAMINATION WAS REQUIRED TO RULE OUT ESOPHAGEAL INJURY AFTER THE REMOVAL OF THE GUIDE WIRE. THE EVENT DID NOT PROLONG THE PATIENT'S HOSPITALIZATION. NO OTHER ADVERSE EFFECTS TO THE PATIENT WERE 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
    2195483 BLUE RHINO G2-MULTI PERCUTANEOUS TRACHEOSTOMY INTRODUCER TRAY JOH TUBE TRACHEOSTOMY AND TUBE CUFF JOH COOK INC N/A 14345680 00827002577169

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention