BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLUE RHINO G2-MULTI PERCUTANEOUS TRACHEOSTOMY INTRODUCER TRAY

    MDR report key: 12627624 · Received October 13, 2021

    Report

    Report Number
    1820334-2021-02321
    Event Type
    Malfunction
    Date Received
    October 13, 2021
    Date of Event
    March 15, 2021
    Report Date
    January 20, 2022
    Manufacturer
    COOK INC
    Product Code
    JOH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ST VINCENT INFIRMARY (UNITED STATES) INFORMED COOK THAT ON (B)(6) 2021, THE BLUE RHINO DILATORS IN BLUE RHINO G2MULTI PERCUTANEOUS TRACHEOSTOMY INTRODUCER SETS (RPN: C-PTISY-100-HC-G-NA-FLEX8.5) WERE NOT AS SMOOTH AS THE PREVIOUS DEVICE MODEL. THE USER NOW ADDS LUBRICANT TO THE BLUE RHINO DILATORS TO ALLOW THEM TO PASS EASIER. THE PATIENT(S) DID NOT EXPERIENCE ADVERSE EFFECTS. A REVIEW OF THE COMPLAINT HISTORY, INSTRUCTIONS FOR USE (IFU), AND QUALITY CONTROL OF THE DEVICE WAS CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE(S) 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 FROM THE USER FACILITY. THOUGH A SEARCH OF SALES LOTS SOLD TO THE CORRESPONDING CUSTOMER WAS COMPLETED, COOK WAS UNABLE TO IDENTIFY THE SPECIFIC COMPLAINT DEVICE LOT(S). GIVEN THE AVAILABLE INFORMATION, COOK HAS CONCLUDED THAT THE DEVICE(S) WAS MANUFACTURED TO SPECIFICATION AND THAT THERE IS NO EVIDENCE SUGGESTING NONCONFORMING PRODUCT EXISTS EITHER IN HOUSE OR IN FIELD. COOK ALSO REVIEWED PRODUCT LABELING. THE PRODUCT IFU, [C_T_PTISGI2_REV0] ¿BLUE RHINO G2-MULTI PERCUTANEOUS TRACHEOSTOMY INTRODUCER", PROVIDES THE FOLLOWING INFORMATION TO THE USER RELATED TO THE REPORTED FAILURE MODE: INSTRUCTIONS FOR USE ¿PATIENT PREPARATION- 6. -THOROUGHLY LUBRICATE TRACHEOSTOMY TUBE ASSEMBLY.¿ ¿TRACHEOSTOMY PROCEDURE- 13. ACTIVATE THE HYDROPHILIC COATING BY IMMERSING THE DISTAL END OF THE BLUE RHINO G2-MULTI DILATOR IN STERILE WATER OR SALINE.¿ BASED ON THE INFORMATION PROVIDED, NO PRODUCT(S) RETURNED, AND THE RESULTS OF OUR INVESTIGATION, A POTENTIAL ROOT CAUSE FOR THIS EVENT HAS BEEN TRACED TO COMPONENT FAILURE UNRELATED TO A DEFICIENCY IN MANUFACTURING/DEVICE DESIGN. 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

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

    Additional Manufacturer Narrative · 1

    PMA/510(K) #: K193133. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BLUE RHINO DILATOR INCLUDED IN THE BLUE RHINO G2-MULTI PERCUTANEOUS TRACHEOSTOMY INTRODUCER TRAY IS NOT AS LUBRICATED AS THE PREVIOUS MODEL, LEADING TO DIFFICULTY ADVANCING THE DILATOR INTO THE AIRWAY. THE PHYSICIAN NOTED THAT THE G2 CONFIGURATION OF THE RHINO HORN, INCLUDING THE CROSS HATCHING AND GROOVES, IS NOT AS SLIPPERY OR LUBRICATED THAN THE PREVIOUS MODEL WITHOUT TEXTURES ON THE HORN. IT NOW TAKES MORE LUBRICANT, AS WELL AS FORCE, TO PASS THE DILATOR INTO THE AIRWAY OF THE PATIENT. PATIENT ANATOMY DID NOT CONTRIBUTE TO THE ISSUE. THERE WERE NO CHANGES IN HOSPITALIZATION AND NO ADVERSE EFFECTS WERE EXPERIENCED BY THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1524441 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