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

Model Number	SFT2601
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product involved in the report has not been returned for evaluation.A review of the device history record is not possible as no lot number was provided.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 29 sep 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
Sunmed holdings llc.Received a single report that referenced second different incidences, which were associated with separate units, involving two different patients.This is the second of two reports.Refer to 3004748541-2025-00069 for the first report it was reported- a patient required continuous positive airway pressure (cpap) after a desaturation episode due to the tubing 'slipping' off for an undetermined amount of time.No additional information was provided concerning the patient's condition or if any medical intervention was required.
Event or Problem Description
Sunmed holdings llc.Received a single report that referenced second different incidences, which were associated with separate units, involving two different patients.This is the second of two reports.Refer to 3004748541-2025-00069 for the first report.It was reported- a patient required continuous positive airway pressure (cpap) after a desaturation episode due to the tubing 'slipping' off for an undetermined amount of time.No additional information was provided concerning the patient's condition or if any medical intervention was required.
Additional Manufacturer Narrative
Correction: b3; d3; d9, d4.Additional information-investigation completion: d4; h2; h6.The product involved in the report has been returned and evaluated.The reported failure could not be reproduced during testing using the salter labs 7900 humidifier at 15lpm (if the product was properly seated on humidifier).The reporter provided a photo of the event and it was noted that the customer likely did not fully seat the connector onto the humidifier.The root cause was determined to be user error.The device history record for lot 537838 was reviewed and the product was produced according to product specifications.All information reasonably known as of 05 jan 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.

• Brand Name: O2 CANNULA
• Common Device Name: INFANT CUSHION NASAL CANNULA 7 FOOT (2.1M) CRUSH-RESISTANT OXYGEN TUBING
• 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: 23175375
• Report Number: 3004748541-2025-00070
• Device Sequence Number: 21235565
• Product Code: CAT
• UDI-Device Identifier: 10889483605714
• UDI-Public: (01)10889483605714(10)537838
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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,Followup
• Report Date (Section B): 01/05/2026

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: SFT2601
• Device Lot Number: 537838
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/22/2025
• Supplement Date Received by Manufacturer: 12/04/2025
• Initial Report FDA Received Date: 09/29/2025
• Supplement Report FDA Received Date: 01/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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