BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTIFLOW JUNIOR NASAL CANNULA

    MDR report key: 3051873 · Received April 10, 2013

    Report

    Report Number
    9611451-2013-00258
    Event Type
    Malfunction
    Date Received
    April 10, 2013
    Date of Event
    November 6, 2012
    Report Date
    November 9, 2012
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    CAT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE COMPLAINT OPT316 OPTIFLOW JUNIOR NASAL CANNULA WAS RETURNED TO FPH IN (B)(4) AND WAS VISUALLY INSPECTED. RESULTS: VISUAL INSPECTION REVEALED THAT THE LEFT TUBE WAS DETACHED FROM THE CANNULA, CONFIRMING THE REPORTED FAULT. THE SPRING WAS EVENLY DISTRIBUTED ALONG ITS LENGTH AND NO DAMAGE WAS OBSERVED. AN ADHESIVE WAS PRESENT AT THE EXTERNAL SURFACE OF THE TUBE THAT WAS INSERTED INTO THE CANNULA. A LOT CHECK WAS NOT PERFORMED AS LOT INFORMATION WAS NOT PROVIDED. CONCLUSION: THE DAMAGE WAS CAUSED BY THE BABY PULLING THE TUBE AWAY FROM THE CANNULA, AS REPORTED BY THE NURSE AT THE HOSPITAL. ALL OPTIFLOW JUNIOR NASAL CANNULAS ARE VISUALLY INSPECTED AND PRESSURE TESTED BEFORE LEAVING THE PRODUCTION LINE, AND THOSE THAT FAIL ARE REJECTED. OUR USER INSTRUCTIONS THAT ACCOMPANY THE OPT316 OPTIFLOW JUNIOR NASAL CANNULA STATE THE FOLLOWING: "CHECK ALL CONNECTIONS, CAPS AND/OR PLUGS ARE TIGHT BEFORE USE." "PATIENT MONITORING IS RECOMMENDED."

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE (FPH) FIELD REPRESENTATIVE THAT THE TUBE OF AN OPT316 OPTIFLOW JUNIOR NASAL CANNULA BECAME DISCONNECTED FROM ITS CANNULA AS THE BABY "RIPPED IT APART". IT WAS FURTHER REPORTED THAT THE COILED WIRE CAME OUT FROM THE TUBE. THERE WERE NO CLINICAL IMPLICATIONS REPORTED AS THE "BABY WAS CRYING AND MOVING A LOT, AND THUS ALREADY HAD HIGH SATURATION".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    152234 OPTIFLOW JUNIOR NASAL CANNULA CAT CAT FISHER & PAYKEL HEALTHCARE LIMITED OPT316 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1