MAUDE Adverse Event Report: SALTER LABS O2 CANNULA; NASAL OXYGEN CANNULA CURVED, FLARED TIP WITH 7 FOOT (2.1M) CRUSH-RESISTANT TUBIN

Model Number	001365
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	08/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The oxygen tubing did not stay in place during the following procedures: gastroscopy, colonoscopy, flexible sigmoidoscopy, bronchoscopy for the vulnerable geriatric patient.The nasal cannula came out; the clamp was very difficult to adjust, and the connection was not tight and came apart easily.This resulted in a delay in treatment/therapy and resulted in minimal (unspecified) harm to the patient.
Additional Manufacturer Narrative
H6: (appropriate term/code not available): minimal (unspecified) harm to the patient.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 16 oct 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 21cfr803, 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
The oxygen tubing did not stay in place during the following procedures: gastroscopy, colonoscopy, flexible sigmoidoscopy, bronchoscopy for the vulnerable geriatric patient.The nasal cannula came out; the clamp was very difficult to adjust, and the connection was not tight and came apart easily.This resulted in a delay in treatment/therapy and resulted in minimal (unspecified) harm to the patient.
Additional Manufacturer Narrative
H6: (appropriate term/code not available): minimal (unspecified) harm to the patient.Correction: d3.Additional information-investigation completion: d4; h2; h6.The actual complaint product was not returned for evaluation; additionally, no photographic/videographic evidence was provided by the reporter.In the absence of a photo or video, the complaint could not confirmed; without a sample to perform functional evaluation, a root cause could not be determined.The device history record for lot 537811 was reviewed and the product was produced according to product specifications.All information reasonably known as of 30 dec 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 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 sun med holdings llc.Product is defective or caused serious injury.

• Brand Name: O2 CANNULA
• Common Device Name: NASAL OXYGEN CANNULA CURVED, FLARED TIP WITH 7 FOOT (2.1M) CRUSH-RESISTANT TUBIN
• Manufacturer (Section D): SALTER LABS; 30 spur dr; parque ind. las americas; el paso, tx 79906 ; MX 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: 23318688
• Report Number: 3004748541-2025-00088
• Device Sequence Number: 17385445
• Product Code: CAT
• UDI-Device Identifier: 10889483570159
• UDI-Public: (01)10889483570159(10)537811(11)250310(17)300310
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Other,Foreign,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/30/2025

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: 001365
• Device Lot Number: 537811
• 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: 09/12/2025
• Supplement Date Received by Manufacturer: 11/30/2025
• Initial Report FDA Received Date: 10/16/2025
• Supplement Report FDA Received Date: 12/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/10/2025
• 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