BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CIAGLIA BLUE RHINO PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET WITH SHILEY

    MDR report key: 8294881 · Received January 31, 2019

    Report

    Report Number
    1820334-2019-00318
    Event Type
    Injury
    Date Received
    January 31, 2019
    Date of Event
    December 29, 2018
    Report Date
    April 25, 2019
    Manufacturer
    COOK INC
    Product Code
    JOH
    PMA / PMN Number
    K133597
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION - EVALUATION. A REVIEW OF THE INSTRUCTIONS FOR USE, QUALITY CONTROL AND SPECIFICATIONS 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 EVALUATION WAS PERFORMED. IT WAS CONCLUDED THAT SUFFICIENT INSPECTION ACTIVITIES ARE IN PLACE TO IDENTIFY THIS FAILURE MODE PRIOR TO DEVICE DISTRIBUTION. A REVIEW OF THE DEVICE HISTORY RECORD FOR THREE POTENTIAL LOT NUMBERS REPORTED BY THE USER FACILITY WAS COMPLETED. NO NONCONFORMANCES WERE FOUND FOR LOT 8993904 AND THE RAW MATERIAL LOT 1842603.5 WAS NOTED TO BE ¿OK¿ UPON INCOMING INSPECTION. THE SECOND LOT 9245880 SHOWED NO NONCONFORMANCES AND THE RAW MATERIAL LOT 1868725.6 WAS NOTED TO BE ¿OK¿ UPON INCOMING INSPECTION. THE FINAL LOT 9102304 SHOWS NO NONCONFORMANCES AND THE RAW MATERIAL LOT WAS FOUND TO BE ¿OK¿ UPON INCOMING INSPECTION. IT SHOULD BE NOTED THAT THERE WAS ONE OTHER COMPLAINT FOR COMPONENT LOT 1842603.5, IN WHICH BLEEDING DURING THE REPLACEMENT OF THE SHILEY TRACHEOSTOMY TUBE WAS REPORTED. ULTIMATELY, NO PROBLEMS WERE DETECTED WITH THE DEVICE REFERENCED IN THAT COMPLAINT. IT WAS CONCLUDED THAT THERE IS NO EVIDENCE THAT NONCONFORMING PRODUCT EXISTS IN HOUSE OR IN THE FIELD. IT WAS DETERMINED DURING THE INVESTIGATION THAT THE AFFECTED COMPONENT IS SUPPLIED TO COOK THROUGH AN EXTERNAL SUPPLIER. THE SHILEY 8-PERC TRACHEOSTOMY TUBE IS SUPPLIED ALREADY PACKAGED AND STERILIZED FROM THE VENDOR AND IS NOT PACKAGED WITH THE COOK C-PTIS-100-WCE-HC-G-PERC8 CIAGLIA BLUE RHINO PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET UNTIL POST-STERILIZATION. COOK INFORMED THE SUPPLIER OF THIS OCCURRENCE AND REQUESTED A SUPPLIER EVALUATION BE CONDUCTED. AS OF 18APR2019, A SUPPLIER INVESTIGATION HAS NOT BEEN RETURNED. THE INSTRUCTIONS FOR USE (IFU), PROVIDES THE FOLLOWING INFORMATION TO THE USER RELATED TO THE REPORTED FAILURE MODE: WARNINGS: ¿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. ASEPTIC TECHNIQUE MUST BE STRICTLY ADHERED TO DURING PLACEMENT OF THIS DEVICE.¿ 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. THE GENEROUS LUBRICATION OF THE LOADING DILATOR SURFACE WILL ENHANCE FIT AND PLACEMENT OF THE TRACHEOSTOMY TUBE.¿ INSTRUCTIONS: ¿POST-PLACEMENT. FOLLOW HOSPITAL PROTOCOL FOR POST-TRACHEOSTOMY CARE AND MAINTENANCE." HOW SUPPLIED: "SUPPLIED STERILIZED BY ETHYLENE OXIDE GAS IN PEEL-OPEN PACKAGES. INTENDED FOR ONE-TIME USE. STERILE IF PACKAGE IS UNOPENED OR UNDAMAGED. DO NOT USE THE PRODUCT IF THERE IS DOUBT AS TO WHETHER THE PRODUCT IS STERILE. STORE IN A DARK, DRY, COOL PLACE. AVOID EXTENDED EXPOSURE TO LIGHT. UPON REMOVAL FROM PACKAGE, INSPECT THE PRODUCT TO ENSURE NO DAMAGE HAS OCCURRED." BASED ON THE INFORMATION PROVIDED, NO RETURNED PRODUCT AND THE RESULTS OF OUR INVESTIGATION, A DEFINITIVE ROOT CAUSE COULD NOT BE ESTABLISHED. PER THE QUALITY ENGINEERING RISK ASSESSMENT, NO FURTHER ACTION IS REQUIRED. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED AND COOK WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. 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 NEW EVENT DESCRIPTION INFORMATION TO REPORT AT THIS TIME.

    Description of Event or Problem · 0

    A COOK REPRESENTATIVE VISITED THE HOSPITAL ON (B)(6) 2019 AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THIS REPORTED EVENT. THE PATIENT¿S PREEXISTING CONDITIONS WERE REPORTED INCORRECTLY. FSD DOES NOT APPLY TO THIS PATIENT. THE PATIENT¿S PREEXISTING CONDITIONS ARE CARDIOGENIC SHOCK AND HEART FAILURE. THE DEVICE WAS PLACED ON (B)(6) 2018 AND THE SORES WERE NOTICED ONE WEEK AFTER THE DEVICE WAS PLACED. THE DEVICE WAS CLEANED DAILY. THE TRACH TIES FROM THE COOK SET WERE USED AND CHANGED AS REQUIRED. GAUZE SWAB WAS USED AS TRACH DRESSING. THEY HAVE CHANGED THE CANNULA FOR ANOTHER. THE PATIENT¿S BEDSORES ARE PRESSURE ULCERS, AT THE STAGE OF NECROSIS OF TISSUES IV LEVEL, BREAKING THE SKIN. THEY DID NOT AFFECT THE PATIENT¿S AIRWAY IN ANY WAY. THE BEDSORES WERE LOCATED EXTERNALLY ON THE SKIN, UNDER THE JUGULAR NOTCH; NOT UNDER THE PILOT NOTCH BUT LOWER. THE PILOT CUFF WAS LOCATED UNDER A DRESSING. AS REPORTED, THE EDGE OF THE PLASTIC PRESSES ON THE SKIN. THE DEVICE IS NOT AVAILABLE FOR EVALUATION AS THEY THREW THE CANNULA IN THE MEDICAL GARBAGE.

    Additional Manufacturer Narrative · 1

    (B)(4). 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 THE PATIENT HAS BEDSORES UNDER THE EXTERNAL CUFF OF SHILEY TRACHEOSTOMY TUBE. ADDITIONAL INFORMATION WAS PROVIDED ON 29JAN2019. THE BEDSORES ARE UNDER THE PILOT CUFF OUTSIDE. THE PATIENT REQUIRED A CHANGE OF DRESSING AND CREAM TO TREAT THE BEDSORES. BEDSORES AND DISCOMFORT WERE REPORTED AS ADVERSE EFFECTS TO THE PATIENT AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    88252 CIAGLIA BLUE RHINO PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET WITH SHILEY JOH TUBE TRACHEOSTOMY AND TUBE CUFF JOH COOK INC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention