BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CIAGLIA BLUE RHINO PERCUTANEOUS TRACHEOSTOMY INTRODUCER TRAY

    MDR report key: 1794949 · Received August 9, 2010

    Report

    Report Number
    1820334-2010-00365
    Event Type
    Malfunction
    Date Received
    August 9, 2010
    Report Date
    July 12, 2010
    Manufacturer
    COOK INC
    Product Code
    DRE
    PMA / PMN Number
    K882796
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NO INFORMATION WAS PROVIDED REGARDING PATIENT OUTCOME/CONSEQUENCE. LEAK(S) IS SPECIFICALLY ADDRESSED IN THE PROVIDED IFU. 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 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 QC. ALTHOUGH A LOT NUMBER WAS NOT PROVIDED, IT IS BELIEVED THAT 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 (B)(4) OF COVIDIEN, 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 25 C-PTISY-100-HC-PERC8 DEVICES THAT WERE INVOLVED IN THE RECALL TO THIS CUSTOMER. THREE RECALL LETTERS HAVE BEEN SENT TO THIS CUSTOMER AND WE ARE STILL AWAITING RETURN OF THE RECALL RESPONSE FORM. IT IS UNCLEAR WHY THE CUSTOMER HAS NOT RETURNED THE REQUIRED FORM OR ANY UNUSED PRODUCT. COOK INCORPORATED PERSONNEL HAVE BEEN IN CONTACT WITH THE CUSTOMER IN REGARDS TO THIS ISSUE IN AN EFFORT TO GET THE CUSTOMER TO COMPLY WITH THE RECALL AND TO STOP USING RECALLED DEVICES IF ANY REMAIN. 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.

    Description of Event or Problem · 1

    TRACH HAD TO BE REMOVED FROM THE PATIENT DUE TO A FAULTY BALLOON. BALLOON WOULD NOT HOLD AIR. (1820334-2010-00364) UPDATE RECEIVED (B)(4) 2010. CUSTOMER HAS EXPERIENCED ON TWO SEPARATE OCCASIONS THE BALLOON LOSING AIR. AFTER 48 HOURS, THE TRACH HAD TO BE REMOVED AND A NEW TRACH PLACED. SPECIFICS ARE UNKNOWN AS TO DATE OF IMPLANT, PRODUCT IDENTIFIERS AND PATIENT INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CIAGLIA BLUE RHINO PERCUTANEOUS TRACHEOSTOMY INTRODUCER TRAY DRE DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION DRE COOK INC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK