MAUDE Adverse Event Report: SALTER LABS DE MEXICO DE S.A. DE C.V. O2 CANNULA; NASAL OXYGEN CANNULA CURVED, FLARED TIP WITH 7 FOOT (2.1M) CRUSH-RESISTANT TUBIN

Model Number	001365
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Low Oxygen Saturation (2477)
Date of Event	06/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product involved in the report has not been returned for evaluation.The documented udi is based on the stock/product code provided by the reporter; the udi-pi is not available as no lot number was provided a review of the device history record is not possible as no lot number was provided.All information reasonably known as of 27 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 three different incidences, which were associated with separate units, involving three different patients.This is the first of three reports.Refer to 3004748541-2025-00054 for the second report.Refer to 3004748541-2025-00055 for the third report.It was reported: the nasal cannual was flared [at the] tip and did not stay in the patients' nares.They we were getting inaccurate 0xygen (o2) sauration levels for the sedated patient, which resulted in [the] patient not getting the required amount of oxygen.[the] patient required more 02 to be delivered by holding the nasal cannula in place.There was no rpeorted injury.
Additional Manufacturer Narrative
Correction: d3; g1.The product involved in the report has not been returned for evaluation.The documented udi is based on the stock/product code provided by the reporter; the udi-pi is not available as no lot number was provided.A review of the device history record is not possible as no lot number was provided.All information reasonably known as of 18 nov 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.
Event or Problem Description
Sunmed holdings llc.Received a single report that referenced three different incidences, which were associated with separate units, involving three different patients.This is the first of three reports.Refer to 3004748541-2025-00054 for the second report.Refer to 3004748541-2025-00055 for the third report.It was reported: the nasal cannual was flared [at the] tip and did not stay in the patients' nares.They we were getting inaccurate 0xygen (o2) sauration levels for the sedated patient, which resulted in [the] patient not getting the required amount of oxygen.[the] patient required more 02 to be delivered by holding the nasal cannula in place.There was no rpeorted 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 DE MEXICO DE S.A. DE C.V.; blvd. independencia #2167; parque ind. las americas; horizonte sur. cd. juarez, mx TX 32596 ; MX 32596
• 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 TX 32596 ; MX 32596
• Manufacturer Contact: racheal cooper ; 2710 north ridge dr nw; ste a; grand rapids, MI
• MDR Report Key: 22908706
• Report Number: 3004748541-2025-00053
• Device Sequence Number: 15157235
• Product Code: CAT
• UDI-Device Identifier: 10889483570159
• UDI-Public: (01)10889483570159
• 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,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/27/2025

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: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/28/2025
• Supplement Date Received by Manufacturer: 10/24/2025
• Initial Report FDA Received Date: 08/27/2025
• Supplement Report FDA Received Date: 11/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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