MAUDE Adverse Event Report: SALTER LABS O2 CANNULA; CANNULA, NASAL, OXYGEN

Model Number	001366
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Airlife nasal cannula reference number 001366 came defective.One side of cannula is not connected to the tubing.

• Brand Name: O2 CANNULA
• Common Device Name: CANNULA, NASAL, OXYGEN
• Manufacturer (Section D): SALTER LABS; 30 spur drive; el paso TX 79906
• MDR Report Key: 23014877
• Report Number: 23014877
• Device Sequence Number: 9741570
• Product Code: CAT
• UDI-Device Identifier: 10889483570166
• UDI-Public: (01)10889483570166
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/19/2025
• Report Date (Section F): 09/04/2025

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
• Device Model Number: 001366
• Device Catalogue Number: 001366
• Device Lot Number: 555395
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Device Age: 4 MO
• Event Location: Hospital
• Date Report to Manufacturer: 09/10/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/10/2025
• 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
• Patient Sex: Unknown
• Date Report Sent to FDA: 09/04/2025