MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; CO2 CANN,MICROFILTER,ADULT,7',NASAL

Catalog Number	HCS4607MN
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/07/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "this cannot connect to the space lab concentratos as they should.Missing the adaptors.Should have been within package but it was not.".
Additional Manufacturer Narrative
The customer reported that the device cannot connect to the space lab concentratos as they should and was missing the adaptors that should have been within the package.Medline quality received a complaint for 1 ea, and complaints of this type are investigated based on the physical sample and use of the item; a retrospective query from july 2023 - december 2023 found no similar complaint(s).Based on the information provided, medline cannot confirm the original complaint.No root cause was identified; medline will notify the manufacturing site of the issue on a quarterly basis and the division will monitor the complaint during quarterly trending.There were no reports of death, serious injury, medical intervention, or follow up care.It has been determined that the reported event could cause or contribute to serious injury if it were to occur again.In an abundance of caution, this is a reportable event.If additional information becomes available this report will be reopened and reevaluated.This medical device report (mdr) is being submitted as part of retrospective review activities, which include review of historical data in accordance with regulations at 21 cfr part 803.The information included in this mdr reflects the information reasonably known to the manufacturer at the time of this retrospective review and submission.

• Brand Name: MEDLINE
• Common Device Name: CO2 CANN,MICROFILTER,ADULT,7',NASAL
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: michael mazeska ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50886855
• Report Number: 1417592-2026-50360
• Device Sequence Number: 18598706
• Product Code: CCK
• UDI-Device Identifier: 20888277728735
• UDI-Public: 20888277728735
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K063813
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial
• Report Date (Section B): 09/24/2026

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
• Device Catalogue Number: HCS4607MN
• Device Lot Number: 40023080188
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/14/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/07/2023
• Initial Report FDA Received Date: 09/24/2026
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown