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

Model Number	001365
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Pressure Sore/Ulcer (2326)
Date of Event	05/07/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
All information reasonably known as of 11 june 2025 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.The information provided by airlife.Represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to airlife.Airlife.Has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the airlife complaint database and identified as complaint (b)(4).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that an airlife product is defective or caused serious injury.
Event or Problem Description
The report of a patient developing sores behind the ears and around the nose after using the nasal flared w/u-connect-it cannula is a reportable incident.It was reported that the patient's sores were being treated by the wound and ostomy nurse, indicating that medical intervention was required.
Additional Manufacturer Narrative
All information reasonably known as of (b)(6) 2025 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.The information provided by airlife.Represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to airlife.Airlife.Has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the airlife complaint database and identified as complaint - (b)(4).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that an airlife product is defective or caused serious injury the complaint of "sores behind the ears/under the nose" regarding part 001365 was not confirmed.The root cause was not determined.A risk assessment was performed, and the ultimate risk was determined to be low which does not require escalation to the capa review board.There have been 1 other complaint regarding the same part and a similar issue within the 24 months preceding this reported event.A resolution letter was sent to the customer.Complaints will continue to be monitored for possible trends.
Event or Problem Description
The report of a patient developing sores behind the ears and around the nose after using the nasal flared w/u-connect-it cannula is a reportable incident.It was reported that the patient's sores were being treated by the wound and ostomy nurse, indicating that medical intervention was required.

• Brand Name: AIRLIFE
• Common Device Name: AIRLIFE¿ NASAL OXYGEN CANNULA CURVED, FLARED TIP WITH 7 FOOT (2.1 M) CRUSH-RESIS
• Manufacturer (Section D): AIRLIFE; 2710 northridge dr nw suite a; grand rapids MI 49544
• Manufacturer (Section G): AIRLIFE(METTAWA); 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: 22188821
• Report Number: 1314417-2025-00037
• Device Sequence Number: 9311310
• Product Code: CAT
• UDI-Device Identifier: 10190752116696
• UDI-Public: (01)10190752116696(10)536538
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/22/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: 001365
• Device Catalogue Number: 001365
• Device Lot Number: 536538
• 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: 05/12/2025
• Supplement Date Received by Manufacturer: 05/12/2025
• Initial Report FDA Received Date: 06/11/2025
• Supplement Report FDA Received Date: 08/22/2025
• 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