BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTIFLOW JUNIOR 2 NASAL CANNULA

    MDR report key: 14467395 · Received May 22, 2022

    Report

    Report Number
    9611451-2022-00478
    Event Type
    Malfunction
    Date Received
    May 22, 2022
    Date of Event
    May 6, 2022
    Report Date
    May 12, 2022
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    CAT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) THE COMPLAINT OJR418 OPTIFLOW JUNIOR 2 NASAL CANNULA IS CURRENTLY EN ROUTE TO FISHER & PAYKEL HEALTHCARE (F&P) FOR EVALUATION. WE WILL PROVIDE A FOLLOW-UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 0

    (B)(4). THE OPTIFLOW JUNIOR CANNULA IS DESIGNED SPECIFICALLY FOR THE DELICATE ANATOMICAL FEATURES AND FLOW REQUIREMENTS OF NEONATAL AND PEDIATRIC PATIENTS. IT FEATURES ADHESIVE PADS (WIGGLEPADS) TO MAINTAIN CANNULA STABILITY ON THE PATIENT'S CHEEKS, SOFT-TOUCH NASAL PRONGS AND BREATHABLE KINK-PROOF AND CRUSH-RESISTANT FLEXIBLE TUBING. METHOD: THE COMPLAINT OJR412 OPTIFLOW JUNIOR 2 CANNULA WAS RECEIVED AT FISHER & PAYKEL HEALTHCARE (F&P) IN NEW ZEALAND FOR EVALUATION WHERE IT WAS VISUALLY INSPECTED. RESULTS: VISUAL INSPECTION OF THE COMPLAINT CANNULA REVEALED THAT ONE OF THE PRONGS WAS MISSING WHILE THE OTHER EDGE OF THE OTHER PRONG WAS ROUGH. CONCLUSION: WE ARE UNABLE TO DETERMINE THE CAUSE OF THE REPORTED FAULT. ALL OPTIFLOW JUNIOR CANNULAS ARE 100% LEAK AND OCCLUSION TESTED AFTER FINAL ASSEMBLY AND ANY CANNULA THAT FAILS IS DISCARDED. MANUFACTURING CONTROLS INCLUDE INSPECTIONS DURING PRODUCTION FOR VISUAL DEFECTS INCLUDING CRACKS, TEARS, INCLUSIONS, DISCOLORATION AND STRETCHING OR DEFORMATION. ANY PRODUCT THAT FAILS THE VISUAL INSPECTION IS DISPOSED OF. THE SUBJECT OJR 412 OPTIFLOW NASAL CANNULA WOULD HAVE MET THE REQUIRED SPECIFICATIONS. THE USER INSTRUCTIONS ILLUSTRATE IN PICTORIAL FORMAT THE CORRECT SET-UP AND PROPER USE OF THE OPTIFLOW JUNIOR 2 NASAL CANNULA. THEY ALSO STATE THE FOLLOWING: - APPROPRIATE PATIENT MONITORING (E.G. OXYGEN SATURATION) MUST BE USED AT ALL TIMES. FAILURE TO MONITOR THE PATIENT (E.G. IN THE EVENT OF AN INTERRUPTION TO GAS FLOW) MAY RESULT IN SERIOUS HARM OR DEATH. - DO NOT WRAP, INSULATE, STRETCH OR CRUSH THE TUBING AS THIS MAY IMPAIR THE PERFORMANCE OF THIS PRODUCT OR COMPROMISE SAFETY (INCLUDING POTENTIALLY CAUSING PATIENT HARM).

    Description of Event or Problem · 0

    A HEALTHCARE FACILITY IN NETHERLANDS REPORTED VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT ONE OF THE PRONGS OF AN OJR412 OPTIFLOW JUNIOR 2 NASAL CANNULA WAS DISINTEGRATED DURING USE. THERE WAS NO REPORTED PATIENT CONSEQUENCE.

    Description of Event or Problem · 0

    A HEALTHCARE FACILITY IN NETHERLANDS REPORTED VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT ONE OF THE PRONGS OF AN OJR412 OPTIFLOW JUNIOR 2 NASAL CANNULA WAS DISINTEGRATED DURING USE. THERE WAS NO REPORTED PATIENT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2365250 OPTIFLOW JUNIOR 2 NASAL CANNULA CAT CAT FISHER & PAYKEL HEALTHCARE LTD OJR412

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown