MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LIMITED FLEXITRUNK INFANT NASAL TUBING; BZO

Model Number	BC190
Health Effect - Clinical Codes	Low Oxygen Saturation (2477); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The complaint bc190 flexitrunk infant nasal tubing is currently en-route to fisher & paykel healthcare (f&p) for evaluation.We will provide a follow up report upon completion of investigation.
Event or Problem Description
A healthcare facility in florida reported via a fisher & paykel healthcare (f&p) representative that the bc190 flexitrunk infant nasal tubing detached from the mask.The patient experienced oxygen desaturation but recovered to a stable condition.The healthcare facility also reported two other patient events that have been reported separately.No further patient consequence was reported.
Additional Manufacturer Narrative
(b)(4).Method: the complaint bc190 flexitrunk infant nasal mask was not returned to fisher & paykel healthcare for evaluation.Our investigation is based on the information provide and our knowledge of our product.Results: the customer reported that the bc190 flexitrunk infant nasal tubing detached from the mask.Conclusion: without the complaint device, we are unable to determine cause of the reported issue with the bc190 flexitrunk infant nasal mask.The user instructions that accompany the flexitrunk infant interface illustrate in pictorial format the correct set-up and proper use of infant interfaces, including the nasal mask and nasal tubing.It also states the following: "connect prongs and mask to nasal tubing ensuring that it is inserted fully." "if using mask: connect to patient by placing mask around the nose.The mask should sit comfortably around the patient's nose.It must not occlude the nostrils or touch the septum and should not be over the lip or over the eyes." "check that all circuit connections are tight before use and after any adjustment.".
Event or Problem Description
A healthcare facility in florida reported via a fisher & paykel healthcare (f&p) representative that the bc190 flexitrunk infant nasal tubing detached from the mask.The patient experienced oxygen desaturation but recovered to a stable condition.The healthcare facility also reported two other patient events that have been reported separately.No further patient consequence was reported.

• Brand Name: FLEXITRUNK INFANT NASAL TUBING
• Common Device Name: BZO
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE LIMITED; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• Manufacturer (Section G): FISHER & PAYKEL HEALTHCARE LIMITED; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• Manufacturer Contact: faranak gomarooni ; 17400 laguna canyon road; suite 300; irvine, CA 92618 ; 9494534002
• MDR Report Key: 14545153
• Report Number: 9611451-2022-00497
• Device Sequence Number: 5195262
• Product Code: BZO
• UDI-Device Identifier: 09420012413390
• UDI-Public: (01)09420012413390(10)2101941803(11)211207
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: BC190
• Device Catalogue Number: BC190
• Device Lot Number: 2101941803
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/09/2022
• Supplement Date Received by Manufacturer: 06/15/2022
• Initial Report FDA Received Date: 05/30/2022
• Supplement Report FDA Received Date: 06/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/07/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown