BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTIFLOW JUNIOR INTERFACE

    MDR report key: 3831678 · Received May 26, 2014

    Report

    Report Number
    9611451-2014-00468
    Event Type
    Malfunction
    Date Received
    May 26, 2014
    Date of Event
    April 27, 2014
    Report Date
    April 29, 2014
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    CAT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE OPTIFLOW JUNIOR CANNULA IS DESIGNED SPECIFICALLY FOR THE DELICATE ANATOMICAL FEATURES AND FLOW REQUIREMENTS OF NEONATAL AND PAEDIATRIC PATIENTS. IT FEATURES ADHESIVE PADS TO MAINTAIN CANNULA STABILITY ON THE PATIENT'S CHEEKS, SOFT-TOUCH NASAL PRONGS AND BREATHABLE KINK-PROOF AND CRUSH-RESISTANT FLEXIBLE TUBING. THE OPTIFLOW JUNIOR PROVIDES A REVOLUTIONARY STEP BETWEEN LOW-FLOW OXYGEN THERAPY AND CPAP. METHOD: THE COMPLAINT OP316 CANNULA WAS RECEIVED AT FISHER & PAYKEL HEALTHCARE (B)(4) AND WAS VISUALLY INSPECTED. A LOT CHECK REVEALED THAT THERE WERE NO SIMILAR COMPLAINTS FOR LOT 131120. CONCLUSION: VISUAL INSPECTION REVEALED THAT THE FLEXITUBE (CANNULA TUBING) HAD BROKEN AWAY FROM THE SWIVEL GRIP THAT CONNECTS TO THE BREATHING CIRCUIT. THE TUBING WAS STRETCHED AND DAMAGED. THE DAMAGE TO THE FLEXITUBE WAS MOST LIKELY CAUSED BY AN EXCESSIVE PULLING FORCE. ALL OPTIFLOW JUNIOR CANNULAE ARE 100% LEAK AND OCCLUSION TESTED AFTER FINAL ASSEMBLY AND ANY CANNULA THAT FAILS IS DISCARDED. IN ADDITION, SAMPLES ARE CURRENTLY TAKEN HOURLY FROM EACH RUN AND PULL TESTED TO CHECK GLUE JOINT STRENGTH AT THE CANNULA/TUBE JOINT, AS WELL AS THE SWIVEL GRIP JOINT. IF THERE ARE ANY FAILURES THE ENTIRE BATCH IS PUT ASIDE FOR FURTHER INVESTIGATION. THE USER INSTRUCTIONS ILLUSTRATE IN PICTORIAL FORMAT THE CORRECT SET-UP AND PROPER USE OF THE OPTIFLOW JUNIOR NASAL CANNULA. THEY ALSO STATE THE FOLLOWING: - ENSURE THAT ALL CONNECTIONS ARE SECURE DURING USE. CHECK CANNULA IS UNDAMAGED AND THAT THE FLOW PATH IS MAINTAINED. - APPROPRIATE MONITORING MUST BE USED AT ALL TIMES. - DO NOT STRETCH OR CRUSH TUBE.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA A FISHER & PAYKEL HEALTHCARE FIELD REPRESENTATIVE THAT THE TUBING OF AN OPT316 OPTIFLOW JUNIOR NASAL CANNULA PULLED APART FROM THE PRONGS WHILE IN USE ON A "SLIGHTLY ACTIVE" (B)(6) PATIENT. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309904 OPTIFLOW JUNIOR INTERFACE CAT CAT FISHER & PAYKEL HEALTHCARE LTD OPT316 131120

    Patients

    Seq Age Sex Outcome Treatment
    1