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

Model Number	BC192-05
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Fisher & paykel healthcare (f&p) are currently in the process of retrieving further information regarding this complaint.We will provide a follow up report upon the completion of our investigation.
Event or Problem Description
A distributor in india reported via a fisher and paykel (f&p) healthcare representative, that bc192 flexitrunk infant nasal tubing was found broken before patient use.There was no patient involvement.
Event or Problem Description
A distributor in india reported via a fisher and paykel (f&p) healthcare representative, that bc192 flexitrunk infant nasal tubing was found broken before patient use.There was no patient involvement.
Additional Manufacturer Narrative
(b)(4).Method: the complaint bc192 flexitrunk infant nasal tubing was not returned to the fisher & paykel healthcare (f&p) for evaluation.Our investigation is therefore based on the information and photograph provided by the customer.Results: the visual inspection of the provided photograph revealed the tubing is damaged.The film is wrinkled and torn.Conclusion: without the complaint device, we are unable to determine the cause of the reported failure.However, it is likely to have been caused by pulling of the tubing.All flexitrunk nasal tubings are visually inspected, and pressure tested before leaving the production line and those that fail are rejected.This suggests that the damage on the subject nasal tubing occurred after it was released for distribution.Our user instructions the accompany the flexitrunk infant nasal tubing state: - "use caution when positioning the infant interface.Avoid excessive pull forces, sharp objects and tubing holders.Damage to the tubing may cause loss of pressure and require immediate replacement." a caution insert is included in the packaging to remind the user to take extra care when handling the flexitrunk.

• 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: 15620679
• Report Number: 9611451-2022-00975
• Device Sequence Number: 6184358
• Product Code: BZO
• UDI-Device Identifier: 09420012413406
• UDI-Public: (01)09420012413406(10)2102117410(11)220401
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/26/2022

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: BC192-05
• Device Catalogue Number: BC192-05
• Device Lot Number: 2102117410
• 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: 09/26/2022
• Supplement Date Received by Manufacturer: 12/02/2022
• Initial Report FDA Received Date: 10/17/2022
• Supplement Report FDA Received Date: 12/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2022
• 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