MAUDE Adverse Event Report: SALTER LABS O2 CANNULA; ADULT CUSHION NASAL CANNULA WITH 7 FOOT (2.1 M) CRUSH-RESISTANT OXYGEN TUBING AN

Model Number	SFT2699
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	Discomfort (2330)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product involved in the report was not returned for evaluation; however, the reporter provided photographic evidence; the complaint was confirmed as reported.The root cause could not be determined.The device history record for lot 553803 was reviewed and the product was produced according to product specifications.All information reasonably known as of 22 aug 2025 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 sun med holdings llc.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 sun med holdings llc.Sun med holdings llc.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 sun med holdings complaint database and identified as (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 an sun med holdings llc.Product is defective or caused serious injury.
Event or Problem Description
Sunmed holdings llc.Received a single report that referenced two different incidences, which were associated with separate units, involving two different patients.This is the first of two reports.It was reported: when used by the patient they complained of [a general] discomfort.A pinhole was found in the middle of the two prongs; there was no reported injury.

• Brand Name: O2 CANNULA
• Common Device Name: ADULT CUSHION NASAL CANNULA WITH 7 FOOT (2.1 M) CRUSH-RESISTANT OXYGEN TUBING AN
• Manufacturer (Section D): SALTER LABS; 30 spur dr; el paso TX 79906
• Manufacturer (Section G): SALTER LABS; 30 spur dr; el paso TX 79906
• Manufacturer Contact: racheal cooper ; 2710 north ridge dr nw; ste a; grand rapids, MI
• MDR Report Key: 22879644
• Report Number: 3004748541-2025-00050
• Device Sequence Number: 18748146
• Product Code: CAT
• UDI-Device Identifier: 10889483605837
• UDI-Public: (01)10889483605837(10)553803(17)300421(11)250421
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/22/2025

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: SFT2699
• Device Lot Number: 553803
• 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: 07/25/2025
• Initial Report FDA Received Date: 08/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/21/2025
• 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