MAUDE Adverse Event Report: VYAIRE MEDICAL VYAIRE MEDICAL, INC; ADAPTER OMNIFLEX PEDIATRIC

Model Number	3215
Medical Device Problem Codes	Material Integrity Problem (2978); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Unspecified Respiratory Problem (4464)
Date of Event	03/20/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The obstruction of airflow to the patient when the adpater is splitm or collapses would cause a loss of oxygen.There is a possiblity of the splintering of the adapter to cause shards that patient could inhale.This would delay patient therapy or ventilation.
Event or Problem Description
Once the plastic collapses, the airflow to my patient is partially obscured.The plastic also looks like it will start to splinter and open, which could potentially cause my patient to inhale plastic shards.
Additional Manufacturer Narrative
The obstruction of airflow to the patient when the adpater is splitm or collapses would cause a loss of oxygen.There is a possiblity of the splintering of the adapter to cause shards that patient could inhale.This would delay patient therapy or ventilation since the reported defect was not confirmed and the root cause was not established no corrective or preventive actions were taken.However, assembly personnel were notified about the complaint.".
Event or Problem Description
Once the plastic collapses, the airflow to my patient is partially obscured.The plastic also looks like it will start to splinter and open, which could potentially cause my patient to inhale plastic shards.

• Brand Name: VYAIRE MEDICAL, INC
• Common Device Name: ADAPTER OMNIFLEX PEDIATRIC
• Manufacturer (Section D): VYAIRE MEDICAL; productos urologos de mexico s; no. 85 parque indust.mexicali; mexicali baja california, mexico 21397 ; MX 21397
• Manufacturer (Section G): VYAIRE MEDICAL; productos urologos de mexico s; no. 85 parque indust.mexicali; mexicali baja california, mexico 21397 ; MX 21397
• Manufacturer Contact: melissa brickley ; 2710 northridge dr nw suite a; grand rapids, MI 49544 ; 6162598415
• MDR Report Key: 19148747
• Report Number: 8030673-2024-01004
• Device Sequence Number: 7548352
• Product Code: BZA
• UDI-Device Identifier: 10190752147690
• UDI-Public: 10190752147690
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 3215
• Device Catalogue Number: 3215
• Device Lot Number: 0004256278
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 03/21/2024
• Initial Report FDA Received Date: 04/19/2024
• Supplement Report FDA Received Date: 05/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown