BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXITRUNK INFANT NASAL TUBING

    MDR report key: 2761251 · Received September 26, 2012

    Report

    Report Number
    9611451-2012-00669
    Event Type
    Malfunction
    Date Received
    September 26, 2012
    Report Date
    August 28, 2012
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BZO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE COMPLAINT BC180 FLEXITRUNK NASAL TUBING WAS RETURNED TO FISHER & PAYKEL HEALTHCARE IN (B)(4) AND WAS VISUALLY INSPECTED FOR THE REPORTED DAMAGE. RESULTS: VISUAL INSPECTION REVEALED A TEAR BETWEEN THE THIRD AND FOURTH SPIRAL IN THE BREATHABLE FILM ON ONE OF THE LIMBS. NO OTHER DAMAGE WAS IDENTIFIED WITH THE RETURNED NASAL TUBING. A LOT CHECK DID NOT REVEAL ANY OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 120417. CONCLUSION: THE TEAR IN THE TUBING WAS ROUGH SUGGESTING THAT THE DAMAGE MAY HAVE OCCURRED AS A RESULT OF ROUGH HANDLING. THE USE OF SUPPORT DEVICES (SUCH AS CHRISTMAS TREES AND ANGEL FRAMES) CAN ALSO DAMAGE THE TUBING. THE USER INSTRUCTIONS THAT ACCOMPANY THE BC180 INFANT NASAL TUBING PROVIDES THE WARNING "USE CAUTION WHEN POSITIONING THE INFANT INTERFACE. SHARP EDGES AND/OR ABRASIVE SURFACES MAY DAMAGE THE PRODUCT". A CAUTION INSERT, WHICH IS INCLUDED IN THE BC180 PACKAGING, REMINDS THE USERS TO TAKE EXTRA CARE WHEN HANDLING THE FLEXITRUNK NASAL TUBING. WE HAVE ONLY RECEIVED TWO OTHER COMPLAINTS OF THIS NATURE.

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT DEVICE IS EN ROUTE TO FISHER & PAYKEL HEALTHCARE IN (B)(4) FOR EVALUATION. WE WILL PROVIDE A FOLLOW UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED TO A FISHER & PAYKEL HELATHCARE REPRESENTATIVE THAT THE NASAL TUBING WAS TORN ON A BC180-05 FLEXITRUNK INFANT NASAL TUBING. NO PATIENT CONSEQUENCE WAS REPORTED.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE REPRESENTATIVE THAT THE NASAL TUBING WAS TORN ON A BC180-05 FLEXITRUNK INFANT NASAL TUBING. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXITRUNK INFANT NASAL TUBING BZO BZO FISHER & PAYKEL HEALTHCARE LTD BC180-05 120417

    Patients

    Seq Age Sex Outcome Treatment
    1 RT235 INFANT BIAS FLOW BREATHING CIRCUIT KIT| RT235 INFANT BIAS FLOW BREATHING CIRCUIT KIT