BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REINFORCED TRACHEAL TUBE CUFFED 7.0MM

    MDR report key: 761417 · Received November 11, 2005

    Report

    Report Number
    8020889-2005-00015
    Event Type
    Malfunction
    Date Received
    November 11, 2005
    Report Date
    October 29, 2004
    Manufacturer
    MALLINCKRODT MEDICAL
    Product Code
    BTR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ACTUAL DEVICE RETURNED FOR EVALUATION. AS LOT NO. WAS PROVIDED FOR THIS REPORT, BATCH PAPERWORK WAS REVIEWED AND CONFIRMS THAT THIS ORDER WAS MANUFACTURED TO MEET ALL BLUEPRINT SPECIFICATIONS AND QUALITY REQUIREMENTS BEFORE FINAL RELEASE. EVALUATION: THE BATCH PAPERWORK FOR LOT NUMBER 2004-04 1066 WAS REVIEWED AND CONFIRMS THAT THE ORDER WAS MANUFACTURED TO MEET ALL OF THE BLUEPRINT SPECIFICATIONS AND QUALITY REQUIREMENTS BEFORE FINAL RELEASE. ONE SAMPLE RETURNED FOR EVALUATION NOT IN ITS ORIGINAL UNIT PACK, BUT IN AN ENVELOPE. VISUAL EXAMINATION OF THE RETURNED UNIT CONFIRMS THAT THE PILOT HAS BEEN CUT OFF THE INFLATION LINE. FURTHER EXAMINATION OF THE RETURNED UNIT FINDS THAT THE MAIN LUMEN OF THE TUBE IS PARTIALLY BLOCKED BY A THIN MEMBRANE OF GLUE. THIS WAS A DEVIATION FROM PROCEDURE AND IT OCCURRED AT THE FLARE AND CONNECT OPERATION. THERE IS EVIDENCE TO SUGGEST THAT THE REPORTED DEFECT OCCURRED IN-HOUSE. A DEVIATION OCCURRED AT THE FLARE AND CONNECT OPERATION WHERE THIS DEFECT SHOULD HAVE BEING DETECTED. AS PART OF THE CORRECTIVE ACTION, ALL OPERATORS WERE INFORMED OF THE SERIOUSNESS OF THIS DEFECT AND THE NEED FOR CONSTANT QUALITY AWARENESS WAS STRESSED TO ALL. AN INCREASED LEVEL OF INSPECTION WAS CARRIED OUT FOR THE NEXT THREE ORDERS PROCESSED. A METHOD AUDIT WAS CARRIED OUT ON ALL OPERATORS COMPLETING THE FLARE AND CONNECT OPERATION. A CORRECTIVE AND PREVENTATIVE ACTION REPORT (CAPA 0047) HAS BEEN RAISED TO DETERMINE THE ROOT CAUSE AND IMPLEMENT CORRECTIVE ACTION. INDIVIDUAL SIZED PINS WERE PUT IN PLACE AT THE FLARE AND CONNECT JIG TO ENSURE NO BLOCKAGES ON THE POST END OF THE CONNECTOR OCCUR. RE-TRAINING WAS CARRIED OUT WITH ALL OPERATORS INVOLVED IN THE FLARE AND CONNECT OPERATION. A STUDY IS CURRENTLY UNDERWAY INVESTIGATING THE USE OF AN ALTERNATIVE BONDING AGENT AND METHOD OF APPLYING SAME.

    Description of Event or Problem · 1

    CLINICIAN FOUND THAT THE MAIN LUMEN OF THE TUBE WAS PARTIALLY BLOCKED BY A THIN MEMBRANE OF GLUE AT THE CONNECTOR END. RE-INTUBATION WAS NOT NECESSARY. NO REPORTED PATIENT HARM OR INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REINFORCED TRACHEAL TUBE CUFFED 7.0MM REINFORCED TRACHEAL TUBE BTR MALLINCKRODT MEDICAL NA 2004-04-1066

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN