MAUDE Adverse Event Report: FLEXITRUNK INFANT NASAL TUBING; BZO

Model Number	BC190
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Low Oxygen Saturation (2477)
Date of Event	01/05/2021
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 our investigation.
Event or Problem Description
A healthcare facility in canada reported via a fisher & paykel healthcare (f&p) field representative that the bc190 flexitrunk infant nasal tubing was found damaged.It was reported that the patient desaturated for a short time but there was no adverse effect.The patient is in a stable condition.
Additional Manufacturer Narrative
(b)(4).Method: the complaint bc190 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 returned device revealed that a section of the upper tube was broken and the evaqua film was torn.Conclusion: the reported damage was most likely caused by the tubing being pulled.All flexitrunk infant nasal tubings are visually inspected and pressure tested during production 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 that 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 canada reported via a fisher & paykel healthcare (f&p) field representative that the bc190 flexitrunk infant nasal tubing was found damaged.It was reported that the patient desaturated for a short time but there was no adverse effect.The patient is in a stable condition.

• Brand Name: FLEXITRUNK INFANT NASAL TUBING
• Common Device Name: BZO
• MDR Report Key: 11267569
• Report Number: 9611451-2021-00114
• Device Sequence Number: 17077952
• Product Code: BZO
• UDI-Device Identifier: 09420012413390
• UDI-Public: (01)09420012413390(10)2100817351(11)190708
• 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: company representative,foreig
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 01/05/2021

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: 2100817351
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2021
• Initial Date Received by Manufacturer: 01/05/2021
• Supplement Date Received by Manufacturer: 02/24/2021
• Initial Report FDA Received Date: 02/02/2021
• Supplement Report FDA Received Date: 02/24/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/08/2019
• 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