BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLUE RHINO G2-MULTI PERCUTANEOUS TRACHEOSTOMY INTRODUCER TRAY

    MDR report key: 14078892 · Received April 11, 2022

    Report

    Report Number
    1820334-2022-00552
    Event Type
    Malfunction
    Date Received
    April 11, 2022
    Report Date
    April 11, 2022
    Manufacturer
    COOK INC
    Product Code
    JOH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL REPORTER OCCUPATION: DIRECTOR OF MED-SURG COMMODITIES. 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

    INVESTIGATION ¿ EVALUATION. (B)(6) HOSPITAL (UNITED STATES) INFORMED COOK ON 18MAY2021 OF AN INCIDENT INVOLVING A C-PTISY-100-HC-G-NA-FLEX8.5 (BLUE RHINO G2-MULTI PERCUTANEOUS TRACHEOSTOMY INTRODUCER TRAY) FROM AN UNKNOWN LOT. IT WAS REPORTED THAT THE DILATOR IS PLIABLE AND WILL BEND, RESULTING IN THE BENDING OF THE GUIDE WIRE. AN ADDITIONAL LIKE, DEVICE WAS OBTAINED TO COMPLETE THE PROCEDURE IN THE OPERATING ROOM. NO ADVERSE EFFECTS TO THE PATIENT WERE REPORTED. REVIEWS OF DOCUMENTATION INCLUDING, QUALITY CONTROL AND INSTRUCTIONS FOR USE (IFU), AS WELL AS A INTERVIEW OF PERSONNEL, WERE CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED; THEREFORE, NO PHYSICAL EXAMINATIONS COULD BE PERFORMED. HOWEVER, A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. A REVIEW OF THE DEVICE MASTER RECORD (DMR) CONCLUDED THAT SUFFICIENT INSPECTION ACTIVITIES ARE IN PLACE TO IDENTIFY THIS FAILURE MODE PRIOR TO DISTRIBUTION. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS UNABLE TO BE COMPLETED DUE TO A LACK OF LOT INFORMATION. COOK REVIEWED THE SALES HISTORY FOR THIS CUSTOMER AND WAS UNABLE TO IDENTIFY THE COMPLAINT LOT. BASED ON THE AVAILABLE INFORMATION, COOK HAS CONCLUDED THAT THERE IS NO EVIDENCE SUGGESTING NONCONFORMING PRODUCT EXISTS EITHER IN HOUSE OR IN FIELD. COOK ALSO REVIEWED PRODUCT LABELING. THE CURRENT INSTRUCTIONS FOR USE [C_T_PTISGI2_REV0] STATE THE FOLLOWING: "HOW SUPPLIED: UPON REMOVAL FROM PACKAGE, INSPECT THE PRODUCT TO ENSURE NO DAMAGE HAS OCCURRED." BASED ON THE AVAILABLE INFORMATION, NO DEVICE RETURN, AND THE RESULTS OF THE INVESTIGATION, COOK HAS CONCLUDED THAT THE CAUSE OF THIS EVENT WAS COMPONENT FAILURE. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED. COOK WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. PER THE RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803 AND IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT CONTAINED HEREIN IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED, THAT A DEATH OR SERIOUS INJURY OCCURRED, NOR THAT ANY COOK DEVICE CAUSED, CONTRIBUTED TO, OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.

    Description of Event or Problem · 0

    CUSTOMER FEEDBACK WAS INITIALLY REPORTED TO COOK REGARDING DILATOR PROVIDED IN THE BLUE RHINO G2-MULTI PERCUTANEOUS TRACHEOSTOMY INTRODUCER TRAY. THE CUSTOMER INDICATED THE DILATOR WAS PLIABLE AND WILL BEND, BENDING THE GUIDE WIRE. ADDITIONAL INFORMATION WAS REQUESTED AND WAS NOT PROVIDED UNTIL (B)(6) 2022 DURING A VIDEO CALL BETWEEN THE CUSTOMER AND THE COOK SALES REPRESENTATIVE. IT WAS AT THIS TIME THAT THIS FAILURE WAS REPORTED TO HAVE OCCURRED TWICE. THE NURSE MANAGER AT THE FACILITY WAS UNABLE TO PROVIDE EXACT DATE OF EVENTS, BUT THIS OCCURRED OVER THE SPAN OF THREE DAYS. ANOTHER KIT WAS USED, AND THE PATIENT WAS TAKEN TO THE OPERATING ROOM. NO ADVERSE EFFECTS TO THE PATIENT OR ADDITIONAL INTERVENTIONS WERE REPORTED DUE TO THE WIRE BENDING.

    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
    1639749 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