MAUDE Adverse Event Report: Salter Labs McKesson; CO2 Sampling Nasal Cannula ADULT, 7' (2.1 m) O2/CO2 SAMPLING LINE WITH MALE LUER

Model Number	16-0503
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	Ear Pain (4812)
Date of Event	08/12/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that after the nasal cannula tubing was placed around the patient's ears and oxygen was initiated at 2 liters per minute, a loud popping sound was heard.Evaluation revealed that the nasal cannula had cracked, causing the noise.The patient became extremely upset and reported ringing and pain in the affected ear.The patient was referred to an ear, nose, and throat (ent) physician for follow-up.No additional patient outcome information was provided.
Additional Manufacturer Narrative
The product involved in the report has not been returned for evaluation.A review of the device history record is in-progress.All information reasonably known as of 10 sept 2026 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.

• Brand Name: McKesson
• Common Device Name: CO2 Sampling Nasal Cannula ADULT, 7' (2.1 m) O2/CO2 SAMPLING LINE WITH MALE LUER
• Manufacturer (Section D): Salter Labs; 30 spur drive; el paso TX 79906
• Manufacturer (Section G): Salter Labs de Mexico de S.A. de C.V.; blvd. independencia #2167; parque ind. las americas cd.; juarez chih, 32575 ; MX 32575
• Manufacturer Contact: candacy bush ; 2710 northridge dr. nw, suite a; grand rapids, MI 49544
• MDR Report Key: 50718041
• Report Number: 3004748541-2026-00156
• Device Sequence Number: 10641069
• Product Code: CAT
• UDI-Device Identifier: 20612479208746
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: Exempt
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/10/2026

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: 16-0503
• Device Catalogue Number: 16-0503
• Device Lot Number: 579890
• 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: 08/12/2026
• Initial Report FDA Received Date: 09/10/2026
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female