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

Model Number	BC4030
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/18/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The complaint bc4030 infant nasal prongs are currently en route to fisher & paykel healthcare new zealand for evaluation.We will provide a follow up report upon completion of investigation.
Event or Problem Description
A healthcare logistics facility in canada reported on behalf of a healthcare facility via a fisher and paykel (f&p) field representative that the one of the nasal prongs of a bc4030 infant nasal prong was detached before use on a patient.It was further reported that scissors were used to open the packaging of the prongs.There was no patient involvement.
Additional Manufacturer Narrative
(b)(4).Method: the complaint bc4030 infant nasal prongs were returned to fisher & paykel healthcare (f&p) in new zealand where it was visually inspected by a trained f&p technician.Results: visual inspection of the complaint bc4030 infant nasal prongs confirmed that one of the nasal prongs was detached.It was also noted that the packaging has been cut off by a sharp object.Conclusion: the most likely cause of the reported issue would be that a sharp object such as a pair of scissors have been used to open the packaging which resulted in cutting off the nasal prongs.The flexitrunk nasal cpap interface is designed to deliver non-invasive positive pressure therapy to a spontaneously breathing patient weighing up to 10 kg in a hospital or clinical setting where the patient is adequately monitored by trained medical staff.The user instructions which accompany the bc4030 infant nasal prongs reveal the following instructions; ·set gas flow to prescribed level.Turn the humidifier on.Refer to manufacturer's instructions.Place hand close to nasal prongs or mask to ensure there is gas flow present.Also, the user instructions reveal the following warnings: ·handle with care.Use caution when positioning or disconnecting the interface.Avoid excessive pull forces, sharp objects and tubing holders.Damage to the tubing may cause loss of pressure and require immediate replacement.·do not use if product or packaging is damaged.·do not modify this product.·use patient oxygen monitoring.·always use pressure monitoring to verify that the patient is receiving the prescribed cpap level.
Event or Problem Description
A healthcare logistics facility in canada reported on behalf of a healthcare facility via a fisher and paykel (f&p) field representative that the one of the nasal prongs of a bc4030 infant nasal prong was detached before use on a patient.It was further reported that scissors were used to open the packaging of the prongs.There was no patient involvement.

• Brand Name: FLEXITRUNK INFANT INTERFACE NASAL PRONGS
• 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: 16402199
• Report Number: 9611451-2023-00118
• Device Sequence Number: 3327691
• Product Code: BZO
• UDI-Device Identifier: 09420012432568
• UDI-Public: (01)09420012432568(10)2102284043(11)220802
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/23/2023

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: BC4030
• Device Catalogue Number: BC4030
• Device Lot Number: 2102284043
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2023
• Supplement Date Received by Manufacturer: 02/26/2023
• Initial Report FDA Received Date: 02/20/2023
• Supplement Report FDA Received Date: 03/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/02/2022
• 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