BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXITRUNK INFANT NASAL PRONGS

    MDR report key: 5988875 · Received September 29, 2016

    Report

    Report Number
    9611451-2016-00608
    Event Type
    Malfunction
    Date Received
    September 29, 2016
    Report Date
    September 2, 2016
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BZO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). LOT NUMBER: 160528, MANUFACTURING DATE: 05/28/2016, QUANTITY AFFECTED: 1. LOT NUMBER: 160603, MANUFACTURING DATE: 06/03/2016, QUANTITY AFFECTED: 1. THE COMPLAINT (B)(4) FLEXITRUNK INFANT NASAL PRONGS ARE EN ROUTE TO FISHER & PAYKEL HEALTHCARE IN (B)(6) FOR INVESTIGATION. WE WILL PROVIDE A FOLLOW-UP REPORT ONCE WE HAVE COMPLETED OUR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). LOT NUMBER: 160528, MANUFACTURING DATE: 05/28/2016, QUANTITY AFFECTED: 1; 160603, 06/03/2016, 1. METHOD: THE ACTUAL COMPLAINT NASAL PRONGS WERE NOT RETURNED TO FPH IN (B)(4) FOR INVESTIGATION. ONE PAIR OF BC6070 FLEXITRUNK INFANT NASAL PRONGS AND TWO BC191 FLEXITRUNK INTERFACE INFANT NASAL TUBINGS, WHICH WERE IN UNSEALED AND USED CONDITIONS, WERE RETURNED INSTEAD. THE RETURNED DEVICES WERE VISUALLY INSPECTED. THE DIMENSIONS OF THE NASAL PRONGS AND THE NASAL TUBING'S MIDLINE CANNULA HOUSING CARRIER WERE ALSO MEASURED, AS PER PART'S RESPECTIVE DRAWINGS. RESULTS: NO PHYSICAL DAMAGE WAS OBSERVED TO THE RETURNED DEVICES. ALL MEASUREMENTS WERE ALSO WITHIN SPECIFICATIONS. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR BOTH LOT NUMBERS. CONCLUSION: NO FAULT WAS FOUND WITH THE RETURNED DEVICES. FPH CURRENTLY MAKES 11 DIFFERENT SIZES OF PRONGS AND RECOGNISES THAT CORRECT CANNULA SIZE SELECTION, CORRECT PRONG PLACEMENT AND FIT AND CAREFUL PATIENT MONITORING ARE VITAL IN ENSURING THE PATIENT RECEIVES THE BENEFITS OF NASAL THERAPY. THE USER INSTRUCTIONS THAT ACCOMPANY THE FLEXITRUNK INFANT INTERFACE ILLUSTRATE THE CORRECT INTERFACE SET-UP ON THE INFANT (INCLUDING SIZING INFORMATION), AND ALSO STATE THE FOLLOWING: - "USE THE SIZING GUIDE TO CHOOSE SUITABLE PRONGS OR MASK." - "PRONGS SHOULD FILL THE NARES COMPLETELY WITHOUT STRETCHING THE SKIN. USE THE BIGGEST POSSIBLE SIZE." - "CHOOSE THE CORRECT LENGTH OF THE NASAL TUBING. USE THE SHORTEST LENGTH POSSIBLE." - "CONNECT PRONGS OR MASK TO NASAL TUBING ENSURING THAT IT IS INSERTED FULLY." - "IF USING PRONGS: SQUEEZE SIDES OF PRONGS FIRMLY TO EXPOSE GROOVES. START FROM ONE END AND INSERT PRONG GROOVES INTO NASAL TUBING. PUSH END IN FIRMLY."

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE (FPH) FIELD REPRESENTATIVE THAT THE BC6060 FLEXITRUNK INFANT NASAL PRONGS WERE POPPING OFF FROM THE NASAL TUBING ABOUT TWO TO THREE TIMES A DAY. THIS WAS OBSERVED DURING USE ON A PATIENT.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE (FPH) FIELD REPRESENTATIVE THAT THE BC6060 FLEXITRUNK INFANT NASAL PRONGS WERE POPPING OFF FROM THE NASAL TUBING ABOUT TWO TO THREE TIMES A DAY. THIS WAS OBSERVED DURING USE ON A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    638131 FLEXITRUNK INFANT NASAL PRONGS BZO BZO FISHER & PAYKEL HEALTHCARE LIMITED BC6060 160528 & 160603

    Patients

    Seq Age Sex Outcome Treatment
    1