MAUDE Adverse Event Report: MCKESSION GENERAL MEDICAL MCKESSON; CO2 SAMPLING NASAL CANNULA ADULT, 10' (3 M) O2/CO2 SAMPLING LINE WITH MALE LUER

Model Number	16-0538
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
While no harm or injury was reported, the air is not passing through the cannula, during patient use, could result in a delay in therapy, and or a lack of oxygen delivery to the patient which could result in serious harm or injury.
Additional Manufacturer Narrative
The product involved in the report has not been returned.A review of the device history record is in-progress.All information reasonably known as of 30 oct 2025 has been included in the 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 is identified as complaint (b)(4).This information is submitted pursuant to 21 cfr 803, in compliance with the medical device reporting requirement and should not be considered to be an admission that a airlife product is defective or causes serious injury.
Additional Manufacturer Narrative
The product involved in the report has not been returned.A review of the device history record is in-progress.All information reasonably known as of 30 oct 2025 has been included in the 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 is 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 a airlife product is defective or causes serious injury the complaint of "the air is not passing through the cannula" regarding part 16-0538 was not confirmed.The root cause was not determined.A risk assessment was performed, and the ultimate risk was determined to be medium but does not require escalation to the capa review board.There have been 3 other complaints 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
While no harm or injury was reported, the air is not passing through the cannula, during patient use, could result in a delay in therapy, and or a lack of oxygen delivery to the patient which could result in serious harm or injury.

• Brand Name: MCKESSON
• Common Device Name: CO2 SAMPLING NASAL CANNULA ADULT, 10' (3 M) O2/CO2 SAMPLING LINE WITH MALE LUER
• Manufacturer (Section D): MCKESSION GENERAL MEDICAL; box 25506; richmond VA 23260
• Manufacturer (Section G): WESTMED JAVID DE MEXICO, S.A. DE C.V; carretera internacional km 6.5; edif 18; parque industrial nog; nogales sonora, mexico 84094 ; MX 84094
• Manufacturer Contact: melissa brickley ; 2710 northridge dr nw suite a; grand rapids, MI 49544 ; 6162598415
• MDR Report Key: 23433212
• Report Number: 2028807-2025-00028
• Device Sequence Number: 11945280
• Product Code: CAT
• UDI-Device Identifier: 00612479208605
• UDI-Public: (01)00612479208605(10)563504
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 12/19/2025

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: 16-0538
• Device Catalogue Number: 16-0538
• Device Lot Number: 563504
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/30/2025
• Supplement Date Received by Manufacturer: 09/30/2025
• Initial Report FDA Received Date: 10/30/2025
• Supplement Report FDA Received Date: 12/29/2025
• 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