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

Model Number	1366
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	Low Oxygen Saturation (2477)
Date of Event	02/02/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.A review of the device history record is not possible as the reporter is unable to confirm the lot number in use at the time of the event.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.All information reasonably known as of 24 mar 2026 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
A failed intubation attempt was reported due to a severely kinked and coiled oxygen tube which lead to inadequate oxygen flow to the neopuff resuscitator causing the patient to desaturate as low as 14%.Ventilation was immediately switched to a flow-inflating resuscitator; the flow was set to 8 l/min, to provide positive pressure ventilation (ppv); adequate chest rise was promptly achieved and the patient's oxygen saturation improved rapidly.The oxygen tubing on the neopuff resuscitator was replaced with a new tube and the patient was successfully intubated on the third attempt.

• Brand Name: 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 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: 24682722
• Report Number: 3004748541-2026-00058
• Device Sequence Number: 18635983
• Product Code: CAT
• UDI-Device Identifier: 20889483570163
• UDI-Public: (01)20889483570163
• 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,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/24/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1366
• Device Lot Number: UNKNOWN
• 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: 02/24/2026
• Initial Report FDA Received Date: 03/24/2026
• 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