BEUDAMED
    FDA Adverse Event Death Summary report: N

    JOH TUBE TRACHEOSTOMY AND TUBE CUFF

    MDR report key: 9732512 · Received February 20, 2020

    Report

    Report Number
    1820334-2020-00409
    Event Type
    Death
    Date Received
    February 20, 2020
    Report Date
    April 6, 2020
    Manufacturer
    COOK INC
    Product Code
    JOH
    PMA / PMN Number
    K133597
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION - EVALUATION: IT WAS REPORTED THAT AN UNKNOWN BLUE RHINO PERCUTANEOUS TRACHEOSTOMY TRAY WAS RELATED TO A PATIENT DEATH. AFTER COMPILING INFORMATION FROM THE CUSTOMER, IT WAS DETERMINED THAT NO ISSUES WERE HAD WITH THE DEVICE OR THE PROCEDURE. AFTER THE TRACHEOSTOMY WAS COMPLETED, THE TRACH TUBE WAS NOT SUTURED IN PLACE. TWO DAYS LATER, THE TRACH TUBE WAS FOUND ON THE FLOOR. COOK BECAME AWARE OF THIS EVENT ON 28JAN2020 UPON BEING NOTIFIED BY PORTSMOUTH REGIONAL HOSPITAL. THE PATIENT REPORTEDLY EXPIRED AS A RESULT OF THIS INCIDENT. A REVIEW OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD (DHR), INSTRUCTIONS FOR USE (IFU) AND QUALITY CONTROL OF THE DEVICE WAS CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED; THEREFORE, NO PHYSICAL EXAMINATIONS COULD BE PERFORMED. HOWEVER, A DOCUMENT-BASED INVESTIGATION EEALUATION WAS PERFORMED. A REVIEW OF THE DEVICE MASTER RECORD (DMR) CONCLUDED THAT SUFFICIENT CONTROLS ARE IN PLACE TO DETECT THIS FAILURE MODE PRIOR TO RELEASE. A REVIEW OF THE DESIGN HISTORY FILES FOUND THAT THIS DEVICE IS BOTH SAFE AND EFFECTIVE FOR ITS INTENDED USE. A REVIEW OF THE DHR WAS UNABLE TO BE COMPLETED DUE TO A LACK OF LOT INFORMATION FROM THE USER FACILITY. GIVEN THIS INFORMATION, COOK HAS CONCLUDED THAT THE DEVICE WAS MANUFACTURED TO SPECIFICATION AND THAT THERE IS NO EVIDENCE TO SUGGEST THAT NON-CONFORMING PRODUCT EXISTS EITHER IN HOUSE OR IN FIELD. THE TRACHEOSTOMY TUBE FOR THIS DEVICE IS SUPPLIED TO COOK BY AN APPROVED VENDOR. HOWEVER, A SUPPLIER INVESTIGATION WAS DEEMED UNNECESSARY AS THE EVENT AND ASSOCIATED INFORMATION DOES NOT SUGGEST A MANUFACTURING-RELATED ISSUE WITH THE DEVICE. COOK ALSO REVIEWED PRODUCT LABELING. INSTRUCTIONS FOR USE (IFU) FOR [CIAGLIA BLUE RHINO® G2 ADVANCED PERCUTANEOUS TRACHEOSTOMY INTRODUCER] IS PACKAGED WITH THIS DEVICE. THE PRODUCT IFU STATES THE FOLLOWING IN CONSIDERATION OF THE REPORTED FAILURE MODE: ¿INTENDED USE: THE CIAGLIA BLUE RHINO G2 ADVANCED PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET/TRAY IS INTENDED FOR PERCUTANEOUS DILATIONAL TRACHEOTOMY FOR MANAGEMENT OF THE AIRWAY IN ADULTS ONLY. TUBE PLACEMENT, USING THE TECHNIQUE DESCRIBED HEREIN, SHOULD BE PERFORMED IN A CONTROLLED SETTING (E.G., ICU OR OPERATING ROOM)WITH THE ASSISTANCE OF TRAINED PERSONNEL. WARNINGS: ONLY PHYSICIANS TRAINED AND EXPERIENCED IN PERCUTANEOUS TRACHEOSTOMY TECHNIQUES SHOULD USE THIS DEVICE. EXERCISE CARE TO ENSURE THAT THE COMPONENTS USED IN EACH STEP ARE PROPERLY POSITIONED WITHIN THE TRACHEA. IMPROPER PLACEMENT OF THE COMPONENTS MAY LEAD TO POTENTIALLY LIFE-THREATENING INJURY. PRECAUTIONS: THIS PRODUCT IS INTENDED FOR USE BY PHYSICIANS TRAINED AND EXPERIENCED IN PERCUTANEOUS TRACHEOSTOMY TECHNIQUES. STANDARD TECHNIQUES FOR PERCUTANEOUS PLACEMENT OF TRACHEOSTOMY TUBES SHOULD BE EMPLOYED. INSTRUCTIONS FOR USE: PATIENT PREPARATION: 1. FOLLOWING THE TRACHEOSTOMY TUBE MANUFACTURER¿S INSTRUCTIONS, TEST THE BALLOON CUFF AND INFLATION SYSTEM. TRACHEOSTOMY PROCEDURE: 20. CONNECT THE TRACHEOSTOMY TUBE TO THE VENTILATOR, INFLATE THE BALLOON CUFF, AND REMOVE THE ENDOTRACHEAL TUBE. 22. IF NECESSARY, ONE SUTURE MAY BE TAKEN AT THE BOTTOM OF THE INITIAL INCISION. POST PLACEMENT: FOLLOW HOSPITAL PROTOCOL FOR POST-TRACHEOSTOMY CARE AND MAINTENANCE.¿ BASED ON THE INFORMATION PROVIDED, NO PRODUCT RETURNED, AND THE RESULTS OF THE INVESTIGATION, A DEFINITIVE ROOT CAUSE WAS TRACED TO UNINTENDED USE ERROR. THE CUSTOMER STATED THAT NO PRODUCT MALFUNCTION WAS EXPERIENCED. IT WAS ALSO REPORTED THAT THE TRACHEOSTOMY TUBE WAS NOT SUTURED IN PLACE AND THAT UNSPECIFIED MISHAPS IN NURSING CARE OCCURRED. THESE FACTORS LIKELY LED TO THE DEVICE LATER BEING FOUND ON THE FLOOR. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED. COOK WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. PER THE QUALITY ENGINEERING 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

    THE PATIENT'S EXACT AGE IS UNKNOWN BUT WAS DESCRIBED TO BE "ELDERLY". THE EXACT DATE OF EVENT IS UNKNOWN BUT WAS DESCRIBED TO BE "THE WEEK AFTER CHRISTMAS" OF 2019. DEVICE NAME: DEVICE IS A CIAGLIA BLUE RHINO PERC. TRAY. REPORTER OCCUPATION: DISTRICT SALES MANAGER. 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 AN ELDERLY MALE PATIENT DIED AFTER A PLANNED PERCUTANEOUS TRACHEOTOMY PROCEDURE IN WHICH AN UNKNOWN DEVICE WAS USED. IT WAS SPECULATED THAT THE POSSIBLE DEVICE WAS A CIAGLIA BLUE RHINO. THE CUSTOMER STATED THAT A PHYSICIAN WHO WAS NOT FORMALLY TRAINED IN PERFORMING PERCUTANEOUS TRACHEOSTOMY PROCEDURES ATTEMPTED THE PROCEDURE BEDSIDE AS PLANNED AND EXPERIENCED UNSPECIFIED ISSUES. DESPITE THESE UNKNOWN ISSUES, THE PLACEMENT PROCEDURE WAS COMPLETED SUCCESSFULLY; HOWEVER, IT WAS NOTED THAT THE PHYSICIAN OPTED NOT TO SUTURE THE TRACHEOSTOMY TUBE IN PLACE. CONSEQUENTLY, TWO DAYS LATER DURING ROUNDS, THE TRACHEOSTOMY TUBE WAS FOUND ON THE FLOOR. NO MALFUNCTION OF THE DEVICE HAS BEEN REPORTED. ADDITIONAL INFORMATION REGARDING THIS EVENT, PATIENT DEMOGRAPHICS, "ISSUES" EXPERIENCED DURING PLACEMENT, AND THE DATE OF THE PATIENT'S DEATH WERE REQUESTED BUT THE CUSTOMER HAS DECLINED TO PROVIDE THIS INFORMATION AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    196179 JOH TUBE TRACHEOSTOMY AND TUBE CUFF JOH COOK INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Death