MAUDE Adverse Event Report: Salter Labs SALTER O2 Cannula; U/Connect-it Oxygen Tubing 7 feet (2.1m) Crush Resistant Oxygen Tubing, Vynil Ti

Model Number	001350
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Codes	Low Oxygen Saturation (2477); Insufficient Information (4580)
Date of Event	06/27/2026
Type of Reportable Event	Malfunction

• Brand Name: SALTER O2 Cannula
• Common Device Name: U/Connect-it Oxygen Tubing 7 feet (2.1m) Crush Resistant Oxygen Tubing, Vynil Ti
• Manufacturer (Section D): Salter Labs; 30 spur dr; el paso TX 79906
• Manufacturer (Section G): Salter Labs de Mexico de S.A. de C.V.; blvd. independencia #2167; parque ind. las americas; horizonte sur. cd. juarez, mx 32596 ; MX 32596
• Manufacturer Contact: racheal cooper ; 2710 north ridge dr nw; ste a; grand rapids, MI
• MDR Report Key: 50132440
• Report Number: 3004748541-2026-00141
• Device Sequence Number: 10527793
• Product Code: BYX
• UDI-Device Identifier: 10889483570111
• UDI-Public: (01)10889483570111(10)575488
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/22/2026

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: 001350
• Device Lot Number: 575488
• 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: 07/06/2026
• Supplement Date Received by Manufacturer: 08/25/2026
• Initial Report FDA Received Date: 08/04/2026
• Supplement Report FDA Received Date: 09/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/22/2025
• 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: Male