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

Model Number	BC192
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/11/2022
Type of Reportable Event	Malfunction
Event or Problem Description
A healthcare facility in (b)(6) reported via a fisher & paykel healthcare (f&p) field representative that a bc192 flexitrunk infant nasal tubing was found torn before use.There was no patient involvement.
Additional Manufacturer Narrative
(b)(4).The complaint bc192 flexitrunk infant nasal tubing is en route to fisher & paykel healthcare (f&p) in (b)(4) for evaluation.We will provide a follow up report upon completion of our investigation.
Additional Manufacturer Narrative
(b)(4) method: the complaint bc192 flexitrunk infant nasal tubing was returned to fisher & paykel healthcare (f&p) in new zealand where it was visually inspected.Results: visual inspection of the return device revealed that the tubing was torn.Conclusion: we are unable to determine the cause of the reported failure.However, it is likely to have been caused by pulling of the nasal 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.
Event or Problem Description
A healthcare facility in germany reported via a fisher & paykel healthcare (f&p) field representative that a bc192 flexitrunk infant nasal tubing was found torn before use.There was no patient involvement.

• 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 ; 173 technology suite drive; suite 100; irvine, CA 92618 ; 9494534000
• MDR Report Key: 13376538
• Report Number: 9611451-2022-00052
• Device Sequence Number: 19956778
• Product Code: BZO
• UDI-Device Identifier: 09420012413406
• UDI-Public: (01)09420012413406(10)2101662315(11)210603
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/12/2022

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
• Device Catalogue Number: BC192
• Device Lot Number: 2101662315
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/12/2022
• Supplement Date Received by Manufacturer: 04/05/2022
• Initial Report FDA Received Date: 01/27/2022
• Supplement Report FDA Received Date: 04/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/03/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: DRAEGER VN500 VENTILATOR; DRAEGER VN500 VENTILATOR; F&P 950 RESPIRATORY HUMIDIFIER; F&P 950 RESPIRATORY HUMIDIFIER; F&P 950N81 NEONATAL VENTILATOR DUAL HEATED CIRCUIT; F&P 950N81 NEONATAL VENTILATOR DUAL HEATED CIRCUIT
• Patient Sex: Unknown