MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; CO2 CANNULA,SSSOFT,ADLT,14'O2 14'CO2,M

Catalog Number	HCS4566S
Medical Device Problem Codes	Material Separation (1562); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/22/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the co2 connection is breaking from the main tubing as pictured below." "we have had about 20 of them break in the last week".
Additional Manufacturer Narrative
The account reported finding co2 connection disconnecting from tubing.Medline quality received one unit; the sample came in two pieces, part of the co2 sampling line was separated at the connection side, approximately 22 inches had come separated, there were multiple tears on the separated section that cut through most of the diameter of the tubing, and measurements found that the tubing and gas sampling lines were made to product specifications.The reported complaint was confirmed with the query.Based on the complaint details the root cause is considered to be a vendor product issue relating to the component manufacturing process, and the complaint was provided to the vendor for further evaluation while the quality team will monitor this issue for trending purposes.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 CANNULA,SSSOFT,ADLT,14'O2 14'CO2,M
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: rylee rosenberg ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50945810
• Report Number: 1417592-2026-54142
• Device Sequence Number: 21444242
• Product Code: CCK
• UDI-Device Identifier: 20888277729060
• UDI-Public: 20888277729060
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 09/29/2026

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: HCS4566S
• Device Lot Number: 40023080060
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/30/2024
• 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: 01/22/2024
• Initial Report FDA Received Date: 09/30/2026
• 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