MAUDE Adverse Event Report: VYAIRE MEDICAL AIRLIFE¿ NASAL OXYGEN CANNULA CURVED, FLARED TIP WITH 7 FOOT (2.1 M) CRUSH-RESIS; CANNULA, NASAL, OXYGEN

Model Number	001365
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/06/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to vyaire medical that the end that connects to the wall oxygen is much more difficult to connect to the green christmas tree.The patient experienced desaturation to 88%.When they looked at the 001365 - cannula nasal flard w/u-connect-it, it had disconnected from the wall.They reconnected the tube to the wall, and saturation increased.The customer confirmed that there was no patient harm/injury associated with the event.
Additional Manufacturer Narrative
Other at this time, the suspect device has not been returned for evaluation.No root cause has been determined yet.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.Device not returned yet.
Additional Manufacturer Narrative
H11:correction.D4:corrected model #.Section d4 was updated to indicate correct model #.

• Brand Name: AIRLIFE¿ NASAL OXYGEN CANNULA CURVED, FLARED TIP WITH 7 FOOT (2.1 M) CRUSH-RESIS
• Common Device Name: CANNULA, NASAL, OXYGEN
• Manufacturer (Section D): VYAIRE MEDICAL; 26125 north riverwoods blvd; mettawa IL 60045
• Manufacturer (Section G): PRODUCTOS UROLOGOS DE MEXICO S.A. DE C.V.; cerrada vía de la producción; parque undustrial mexicali iii; mexicali 21397 ; MX 21397
• Manufacturer Contact: sandra valencia ; 510 technology drive; irvine, CA 92618 ; 2402760001
• MDR Report Key: 18331315
• Report Number: 8030673-2023-00361
• Device Sequence Number: 17841944
• Product Code: CAT
• UDI-Device Identifier: 10190752116696
• UDI-Public: (01)10190752116696
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/14/2023

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: 001365
• Device Catalogue Number: 001365
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/16/2023
• Supplement Date Received by Manufacturer: 08/05/2024
• Initial Report FDA Received Date: 12/14/2023
• Supplement Report FDA Received Date: 08/05/2024
• 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: Required Intervention
• Patient Sex: Unknown