BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT INTERFACE NASAL PRONGS

    MDR report key: 2874853 · Received December 16, 2012

    Report

    Report Number
    9611451-2012-00917
    Event Type
    Malfunction
    Date Received
    December 16, 2012
    Report Date
    November 22, 2012
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BZO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT DEVICE IS NOT EXPECTED TO BE RETURNED TO FPH FOR INSPECTION. WE ARE CURRENTLY IN THE PROCESS OF OBTAINING FURTHER INFORMATION FROM THE DISTRIBUTOR IN ORDER TO ASSIST US WITH THE ANALYSIS AND IDENTIFICATION OF A POSSIBLE ROOT CAUSE OF THE EVENT AS REPORTED. WE WILL PROVIDE A FOLLOW UP REPORT ONCE WE HAVE COMPLETED OUR ANALYSIS.

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT CODE WAS CHANGED FROM BC5040 TO BC5550 BASED ON THE ADDITIONAL INFORMATION PROVIDED BY THE DISTRIBUTOR. THE COMPLAINT BC5550 NASAL PRONGS WERE NOT RETURNED TO FISHER & PAYKEL HEALTHCARE IN (B)(4) AS IT WAS DISCARDED AT THE HEALTHCARE FACILITY. OUR ANALYSIS IS ACCORDINGLY BASED ON THE EVENT DESCRIPTION, ADDITIONAL INFORMATION PROVIDED BY THE DISTRIBUTOR, AND OUR KNOWLEDGE OF THE PRODUCT. A HEALTHCARE FACILITY REPORTED VIA THE DISTRIBUTOR THAT A (B)(6) FEMALE INFANT, WEIGHING (B)(6) AT THE TIME OF THE INCIDENT, ALLEGEDLY SUSTAINED LACERATION AT THE RIGHT NOSTRIL DUE TO THE "VERY HARD AND STIFF" SILICONE MATERIAL OF THE BC5550 NASAL PRONGS. THE NASAL PRONGS WERE USED IN CONJUNCTION WITH BC161 BUBBLE CPAP SYSTEM, BC309 INFANT INTERFACE BONNET, AND BC182 INFANT INTERFACE NASAL TUBING, WHICH ARE THE CORRECT PRODUCTS FOR THE WEIGHT OF THE INFANT. FURTHER INFORMATION RECEIVED FROM THE HEALTHCARE FACILITY REVEALED THAT "THEY HAVE MORE THAN 2 YEARS EXPERIENCE WITH THE CARE OF PATIENTS WITH MASKS AND PRONGS INTERFACES AND THAT THEY HAVE RECEIVED THE NECESSARY TRAINING FOR THE PROPER FUNCTIONING OF THE EQUIPMENT AND THE CARE OF THESE PATIENTS". WE HAVE ATTEMPTED TO FOLLOW UP WITH THE HEALTHCARE FACILITY TO UNDERSTAND WHY THEY ARE DESCRIBING THE BC5550 AS "VERY HARD AND STIFF". WE HAVE REQUESTED THAT EITHER THE COMPLAINT NASAL PRONGS BE RETURNED OR SIMILAR SAMPLES BE PROVIDED SO THAT WE CAN UNDERSTAND WHAT THEY ARE REFERRING TO. HOWEVER, THE HEALTHCARE FACILITY DISPOSED OF THE COMPLAINT NASAL PRONGS AND HAS NOT BEEN ABLE TO PROVIDE US WITH SIMILAR SAMPLES. WITHOUT A SAMPLE, AND WITHOUT FURTHER CLARIFICATION FROM THE HEALTHCARE FACILITY, WE ARE UNABLE TO CONFIRM THE FAULT. THE INFANT INTERFACE NASAL PRONGS ARE SOFT AND PLIABLE, AND ARE MADE FROM SOFT SILICONE MATERIAL. THE NASAL PRONGS ARE ANATOMICALLY CURVED FOR COMFORTABLE FIT. THE DELICATE TISSUE AROUND THE NASAL SEPTUM CAN BREAK DOWN IF SUBJECTED TO CONTINUOUS PRESSURE, FRICTION, OR MOISTURE. THE USER INSTRUCTIONS THAT ACCOMPANY THE FLEXITRUNK INFANT INTERFACE ILLUSTRATE THE CORRECT INTERFACE SET-UP ON THE INFANT, AND ALSO STATE THE FOLLOWING CHECKS DURING USE: "IF USING PRONGS: CLEAR NASAL SECRETIONS BEFORE INSERTING THE NASAL PRONGS." "CHECK PATIENT FREQUENTLY FOR SIGNS OF REDNESS, PRESSURE SORES OR IRRITATION WHICH MAY RESULT FROM EXTENDED PRONG OR MASK USE. HOURLY CHECKS ARE RECOMMENDED." "ALTERNATING BETWEEN MASK AND PRONGS CAN REDUCE THE RISK OF IRRITATION. ALTERNATING EVERY 4 TO 6 HOURS IS RECOMMENDED." THE HEALTHCARE FACILITY DID NOT PROVIDE THE CURRENT STATUS OF THE INFANT; HOWEVER, NO SPECIFIC MEDICAL OR SURGICAL INTERVENTION WAS REPORTED AS A RESULT OF THE INCIDENT. FPH HAS NOT RECEIVED COMPLAINTS OF ANY SIMILAR INCIDENTS FOR INFANT INTERFACE NASAL PRONGS.

    Description of Event or Problem · 1

    A DISTRIBUTOR IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE (FPH) FIELD REPRESENTATIVE THAT A BC5550 INFANT INTERFACE NASAL PRONGS ALLEGEDLY CAUSED A GRADE 1 LACERATION AT THE RIGHT NOSTRIL OF AN INFANT'S NOSE AFTER FEW DAYS OF USE. IT WAS FURTHER REPORTED THAT THE SILICONE MATERIAL OF THE COMPLAINT NASAL PRONGS WAS "VERY HARD AND STIFF". NO MEDICAL OR SURGICAL INTERVENTION WAS REPORTED AS A RESULT OF THIS INCIDENT. THE INFORMATION PROVIDED BY THE HEALTHCARE FACILITY IS NOT CLEAR; HOWEVER, IT APPEARS THAT THE REPORTED INJURY WAS NOT CONSIDERED SEVERE.

    Description of Event or Problem · 1

    A DISTRIBUTOR IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE (FPH) FIELD REPRESENTATIVE THAT THE BC5040 INFANT INTERFACE NASAL PRONGS ALLEGEDLY CAUSED LACERATION AT THE RIGHT NOSTRIL OF THE BABY'S NOSE AFTER FEW DAYS OF USE. IT WAS FURTHER REPORTED THAT THE SILICON MATERIAL OF THE COMPLAINT NASAL PRONGS WAS "VERY HARD AND STIFF". NO MEDICAL OR SURGICAL INTERVENTION WAS REPORTED AS A RESULT OF THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFANT INTERFACE NASAL PRONGS BZO BZO FISHER & PAYKEL HEALTHCARE LIMITED BC5550 NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1