MAUDE Adverse Event Report: Salter Labs SALTER O2 Cannula; Nasal Oxygen Cannula Curved, Non-Flared Tip with 7-foot (2.1m) Crush-Resistant

Model Number	001366
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction

• Brand Name: SALTER O2 Cannula
• Common Device Name: Nasal Oxygen Cannula Curved, Non-Flared Tip with 7-foot (2.1m) Crush-Resistant
• Manufacturer (Section D): Salter Labs; 30 spur dr; el paso TX 79906
• Manufacturer (Section G): Salter Labs dba AirLife de Mexico de S.A.; blvd. independencia #2167; parque ind. las americas; horizonte sur. cd. juarez, mx ; MX
• Manufacturer Contact: racheal cooper ; 2710 north ridge dr nw; ste a; grand rapids, MI
• MDR Report Key: 50724141
• Report Number: 3004748541-2026-00157
• Device Sequence Number: 18255426
• Product Code: CAT
• UDI-Device Identifier: 20889483570163
• UDI-Public: (01)20889483570163(10)581278(11)251208(17)301208
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 001366
• Device Lot Number: 581278
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/12/2026
• Initial Report FDA Received Date: 09/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/08/2025
• 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
• Patient Sex: Unknown