MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD INFANT NASAL MASK; BYG

Model Number	BC802
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/03/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Fisher & paykel healthcare (f&p) is currently in the process of completing our investigation.We will provide a follow up report upon completion of our investigation.
Event or Problem Description
A healthcare facility in australia reported that a bc802 infant nasal mask was found damaged.There was no patient involvement as the issue was found whilst the device was not in use on a patient.
Event or Problem Description
A healthcare facility in australia reported that a bc802 infant nasal mask was found damaged.There was no patient involvement as the issue was found whilst the device was not in use on a patient.
Additional Manufacturer Narrative
Ps448932 method: the complaint bc802 infant nasal mask was received at fisher & paykel healthcare (f&p) new zealand, where it was visually inspected.Results: visual inspection of the complaint device revealed that the mask had cut damage on the left side of the mask.The edges are clean, indicating that the mask has been cut by a sharp instrument such as scissors.The damage was able to be replicated by cutting the right side of the mask with scissors.Conclusion: based on our knowledge of the product, the mask was likely subjected to damage from the user.The end user may have used a sharp instrument such as scissors to open the package, resulting in the observed damage.Our user instructions which accompany the flexitrunk nasal cpap interface state: - "handle with care.Use caution when positioning or disconnecting to 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.".

• Brand Name: INFANT NASAL MASK
• Common Device Name: BYG
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE LTD; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• Manufacturer (Section G): FISHER & PAYKEL HEALTHCARE LTD; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• Manufacturer Contact: diego banuelos ; 17400 laguna canyon road; suite 300; irvine, CA 92618 ; 9494341005
• MDR Report Key: 19399233
• Report Number: 9611451-2024-00399
• Device Sequence Number: 6946156
• Product Code: BYG
• UDI-Device Identifier: 09420012432698
• UDI-Public: (01)09420012432698(10)2102990684(11)240214
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/03/2024

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: BC802
• Device Catalogue Number: BC802
• Device Lot Number: 2102990684
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/03/2024
• Supplement Date Received by Manufacturer: 07/24/2024
• Initial Report FDA Received Date: 05/26/2024
• Supplement Report FDA Received Date: 08/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/14/2024
• 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