BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLUE RHINO G2-MULTI PERCUTANEOUS TRACHEOSTOMY INTRODUCER TRAY

    MDR report key: 12721833 · Received October 29, 2021

    Report

    Report Number
    1820334-2021-02411
    Event Type
    Malfunction
    Date Received
    October 29, 2021
    Date of Event
    April 26, 2021
    Report Date
    January 28, 2022
    Manufacturer
    COOK INC
    Product Code
    JOH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: H6 - ANNEX G. INVESTIGATION-EVALUATION: ON (B)(6) 2021, COOK MEDICAL INCORPORATED RECEIVED A COMPLAINT FROM (B)(6), A REPRESENTATIVE AT THE (B)(6) HEALTH SYSTEM INC., LOCATED IN (B)(6). IT WAS REPORTED THAT THE ATTENDING PHYSICIAN HAD DIFFICULTY ADVANCING THE LOADING DILATOR INTO THE TRACHEOSTOMY TUBE. THE LOADING DILATOR WAS A COMPONENT OF THE COOK BLUE RHINO G2-MULTI PERCUTANEOUS TRACHEOSTOMY INTRODUCER TRAY, RPN: C-PTISY-100-HC-G-NA-FLEX8.5, LOT NUMBER UNKNOWN. THE PHYSICIAN STATED THE LOADING DILATOR WOULD NOT FIT. THE PHYSICIAN ATTEMPTED USING EVERY SIZE DILATOR THAT IS PROVIDED IN THE COOK BLUE RHINO G2-MULTI PERCUTANEOUS TRACHEOSTOMY INTRODUCER TRAY. THE TRACHEOSTOMY TUBE WAS PLACED. HOWEVER, DETAILS REGARDING THE COMPLETION OF THE PROCEDURE WERE NOT PROVIDED. REVIEWS OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD (DHR), INSTRUCTIONS FOR USE (IFU), AND QUALITY CONTROL OF THE DEVICE WERE CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED; THEREFORE, NO PHYSICAL EXAMINATIONS COULD BE PERFORMED. ADDITIONALLY, 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 DESIGN HISTORY FILE (DHF) SHOWED THAT THIS DEVICE IS BOTH SAFE AND EFFECTIVE FOR ITS INTENDED USE. THE CUSTOMER DID NOT PROVIDE A LOT NUMBER FOR THE C-PTISY-100-HC-G-NA-FLEX8.5, BLUE RHINO G2-MULTI PERCUTANEOUS TRACHEOSTOMY INTRODUCER TRAY. THEREFORE, COOK MEDICAL PERFORMED AN EXPANDED SALES SEARCH OF ALL C-PTISY-100-HC-G-NA-FLEX8.5, BLUE RHINO G2-MULTI PERCUTANEOUS TRACHEOSTOMY INTRODUCER TRAYS SHIPPED TO THIS CUSTOMER BETWEEN (B)(6), HAVING FOUND 7 LOTS. A SEARCH OF THESE LOTS CONFIRMED NO RECORDED NONCONFORMANCE AND OR COMPLAINTS. BASED ON THE AVAILABLE INFORMATION, COOK HAS CONCLUDED THAT THE DEVICE 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 IFU (C_T_PTISGI2_REV0) SUPPLIED WITH THE DEVICE STATES THE FOLLOWING IN CONSIDERATION OF THE REPORTED FAILURE MODE: INSTRUCTIONS FOR USE, PATIENT PREPARATION, ...6. GENEROUSLY LUBRICATE THE SURFACE OF THE APPROPRIATELY SIZED LOADING DILATOR AND LOAD THE TRACHEOSTOMY TUBE ONTO THE DILATOR. ENSURE THAT THE TRACHEOSTOMY TUBE'S TIP FITS SNUGLY ON THE DILATOR. ENSURE THAT THE BALLOON IS COMPLETELY DEFLATED. THOROUGHLY LUBRICATE TRACHEOSTOMY TUBE ASSEMBLY." PRODUCT RECOMMENDATIONS, RECOMMENDED LOADING DILATOR SIZES AND ASSOCIATED TRACHEOSTOMY TUBES, (CHART PROVIDED), COMPATIBILITY TESTING WAS PERFORMED WITH SHILEY FLEX AND SHILEY EVAC TRACHEOSTOMY TUBES. WHEN USING ANOTHER APPROPRIATELY SIZED TRACHEOSTOMY TUBE, ENSURE THAT THE TRACHEOSTOMY TUBE'S TIP FITS SNUGLY ON THE DILATOR. "SHILEY" IS A REGISTERED TRADEMARK OF COVIDIEN LP" BASED ON THE INFORMATION PROVIDED, NO PRODUCT RETURNED, AND THE RESULTS OF THE INVESTIGATION A ROOT CAUSE HAS BEEN TRACED TO USER ERROR. INFORMATION COLLECTED BY COOK PERSONNEL INDICATES THAT THE EVENT MAY HAVE BEEN CAUSED BY AN INTERACTION WITH THE USER AND THE DEVICE OR THE IMPROPER SELECTION OF THE APPROPRIATE SIZED LOADING DILATOR FOR THE TRACHEOSTOMY TUBE USED. 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

    OCCUPATION: RESPIRATORY COORDINATOR. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DIFFICULTY WAS EXPERIENCED WHEN ATTEMPTING TO ADVANCE THE LOADING DILATOR INTO THE TRACHEOSTOMY TUBE INCLUDED IN A BLUE RHINO G2-MULTI PERCUTANEOUS TRACHEOSTOMY INTRODUCER TRAY. THE PHYSICIAN TRIED TO LOAD THE DILATOR ONTO THE TRACHEOSTOMY TUBE, BUT FOUND THAT IT DID NOT FIT. THIS WAS ATTEMPTED WITH EVERY SIZE DILATOR PROVIDED IN THE TRAY. THE TRACHEOSTOMY TUBE WAS ABLE TO BE PLACED AND THE REST OF THE LOADING DILATORS AND PIECES THAT WERE INCLUDED IN THE KIT WERE DISPOSED OF AFTER THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1620124 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