MAUDE Adverse Event Report: SALTER LABS MEDLINE; SUPERSOFT ADULT CO2 CANNULA W/ 7FT TUBING & FEMALE LEUR

Model Number	HCS4568S
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	Low Oxygen Saturation (2477)
Type of Reportable Event	Malfunction
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 second of two reports.Refer to 1314417-2026-00017 for the first report.It was reported, the oxygen and carbon dioxide (co2) lines and prongs were reversed and the patient were not getting any oxygen.There was no report of serious harm or injury as a result of this reported event.
Additional Manufacturer Narrative
The product involved in the reported incident has not been returned for evaluation.A review of the device history record is not possible as no lot number was provided.Udi: 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 01 apr 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 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: MEDLINE
• Common Device Name: SUPERSOFT ADULT CO2 CANNULA W/ 7FT TUBING & FEMALE LEUR
• 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: 24760983
• Report Number: 1314417-2026-00018
• Device Sequence Number: 15764967
• Product Code: CCK
• UDI-Device Identifier: 10888277716780
• UDI-Public: (01)10888277716780
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: UNKNOWN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2026

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: HCS4568S
• Device Catalogue Number: HCS4568S
• Device Lot Number: UNKNOWN
• 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: 03/02/2026
• Supplement Date Received by Manufacturer: 05/27/2026
• Initial Report FDA Received Date: 04/01/2026
• Supplement Report FDA Received Date: 06/26/2026
• 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