BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CIAGLIA BLUE RHINO PERCUTANEOUS TRACHEOSTOMY INTRODUCER TRAY

    MDR report key: 2865250 · Received September 16, 2010

    Report

    Report Number
    1820334-2010-00469
    Event Type
    Injury
    Date Received
    September 16, 2010
    Date of Event
    August 20, 2010
    Report Date
    August 24, 2010
    Manufacturer
    COOK, INC.
    Product Code
    DQO
    PMA / PMN Number
    K882796
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    EXPIRATION REPORTED TO BE 03/2014, BUT CANNOT BE VERIFIED AS LOT IS UNKNOWN. (B)(4). THE 6 PERC AND 8 PERC TRACHEOSTOMY TUBES ARE PURCHASED FROM AN APPROVED VENDOR THAT CURRENTLY SUPPLIES THESE PRODUCTS DIRECTLY TO MEDICAL PRACTITIONERS AS WELL AS TO COOK INC. THE APPROPRIATE DESIGN CONTROL ACTIVITIES HAVE BEEN PERFORMED. THE INSTRUCTIONS FOR USE (IFU) PROVIDED WITH EACH SHILEY 6 PERC AND 8 PERC DEVICE STATES, "ALWAYS TEST THE CUFF AND INFLATION SYSTEM FOR LEAKAGE BEFORE INSERTING THE TUBE. THIS TEST CAN BE PERFORMED AS FOLLOWS: INFLATE THE CUFF WITH THE VOLUME OF AIR INDICATED IN TABLE TWO ON PAGE 2. THEN EITHER OBSERVE (VISUALLY INSPECT) FOR DEFLATION OVER SEVERAL MINUTES OR IMMERSE THE TUBE IN STERILE SALINE AND OBSERVE FOR AIR LEAKAGE. DEFLATE THE CUFF PRIOR TO INSERTION." ADDITIONALLY, THE IFU STATES, "SIMPLE PRECAUTIONS IN HANDLING OF THE SHILEY PERCUTANEOUS DUAL CANNULA TRACHEOSTOMY TUBE WITH CUFF DURING INSERTION AND WHILE IN PLACE WILL FACILITATE PROPER FUNCTION AND MINIMIZE TEARS AND BREAKS IN THE INFLATION SYSTEM," THE SUPPLIER PERFORMS A LEAK TEST AT FINAL QUALITY CONTROL. THE DIRECTOR OF PRODUCT MONITORING HAS BEEN THE PRIMARY SOURCE OF COMMUNICATION AND COORDINATION RELATING TO THE RECALL FROM OUR VENDOR COVIDIEN. ALTHOUGH A COOK LOT NUMBER WAS NOT PROVIDED, THE SUBJECT PRODUCT INVOLVED IN THIS COMPLAINT CAME FROM ONE OF THE LOTS RECALLED BY COVIDIEN. THE COVIDIEN RECALL INVOLVED 6 PERC LOT NUMBERS 0810002450 THROUGH 0908000782 AND 8 PERC LOTS 0810002453 THROUGH 0908000797. AS A RESULT OF THE VENDOR RECALL, COOK INCORPORATED RECALLED ALL PRODUCTS CONTAINING THE PREVIOUSLY REFERENCED LOT NUMBERS. ACCORDING TO COVIDIEN PERSONNEL, THE RECALLED LOTS CORRELATE TO A TIME FRAME IN WHICH COVIDIEN TRANSFERRED MANUFACTURING OF THE PILOT BALLOON ASSEMBLY FROM ONE OF THEIR VENDORS TO A COVIDIEN INTERNAL PROCESS. MANUFACTURING OF THE PILOT BALLOON HAS SINCE BEEN TRANSFERRED BACK TO THE ORIGINAL VENDOR. COOK INCORPORATED SHIPPED 3 C-PTISY-100-HC-PERC8 DEVICES THAT WERE INVOLVED IN THE RECALL TO THIS CUSTOMER. RECALL LETTERS WERE SENT TO THIS CUSTOMER AND A RECALL RESPONSE FORM WAS RETURNED ON (B)(4) 2010. ADDITIONALLY, A PRODUCT RECALL EFFECTIVENESS CHECK WAS RECEIVED ON (B)(4) 2010. HOWEVER, ON BOTH OF THESE FORMS, THE CUSTOMER HAS LISTED AFFECTED PRODUCT THAT IS NOT SUPPLIED BY COOK MEDICAL. THIS PRODUCT HAS BEEN RECALLED BY BOTH COVIDIEN AND COOK INCORPORATED. COVIDIEN HAS ALREADY INITIATED AND IMPLEMENTED CORRECTIVE ACTION IN RELATION TO THIS ISSUE, INCLUDING TRANSFERRING MANUFACTURING OF THE PILOT BALLOON BACK TO THE ORIGINAL VENDOR AND INCREASING THE VERIFICATION TESTING PERFORMED ON THE PILOT BALLOON ITSELF. WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED. ADDITIONAL INFORMATION FROM THE USER FACILITY REPORT: BRAND NAME: SHILEY PERC8 TRACHEOSTOMY TUBE, COMMON DEVICE NAME: PERCUTANEOUS TRACHEOSTOMY TUBE, (B)(6).

    Description of Event or Problem · 1

    ON (B)(6) 2010, THE PATIENT WAS TAKEN TO SURGERY FOR A TRACHEOSTOMY, AN 8 PERC PERCUTANEOUS TRACHEOSTOMY TUBE WAS INSERTED. ON (B)(6) 2010, RESPIRATORY THERAPIST NOTED GURGLING AROUND THE CUFF, THE CUFF HAD TO BE REINFLATED ON MORE THAN ONE OCCASION. FURTHER INVESTIGATION REVEALED THAT THE LOT NUMBER ON THE TRACHEOSTOMY TUBE (TRACH TUBE WAS PART OF A CIAGLIA BLUE RHINO PERCUTANEOUS TRACHEOSTOMY INTRODUCER KIT) WAS ONE OF THE LOT NUMBERS INCLUDED IN COVIDIEN'S SHILEY PERCUTANEOUS TRACH RECALL. ON (B)(6) 2010, DURING THE REMOVAL AND REPLACEMENT OF THE TRACHEOSTOMY TUBE THERE WERE DIFFICULTIES IN VENTILATING THE PATIENT DUE TO HIGH PRESSURES, THE PATIENT BECAME BRADYCARDIC AND WENT INTO PEA. A CODE WAS CALLED, DURING THE CODE COPIOUS AMOUNTS OF CLOT WERE SUCTIONED; THE PATIENT SURVIVED. LATER A FIBEROPTIC BRONCHOSCOPY WAS PERFORMED WITH REMOVAL OF THICK CLOTS. THE PATIENT SURVIVED. NO ADDITIONAL PATIENT DETAILS WERE PROVIDED BY THE REPORTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CIAGLIA BLUE RHINO PERCUTANEOUS TRACHEOSTOMY INTRODUCER TRAY DQO CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO COOK, INC. NA 09030008753

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention