MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; CLEARPRO,CLOSED SXN,14FR,D SWVL,ETT

Catalog Number	DYNCPDS14
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/06/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "while suctioning, hub of catheter broke off and lodged in vent circuit.".
Additional Manufacturer Narrative
The account reported finding "cath broke off," and the complaint states that rt needed to use forceps to retrieve the broken piece before it reached patient; no injury was reported.No sample or photo was received for the investigation; based on the vendor's response, the dhr was reviewed along with the incoming inspection and shipping records and no similar abnormalities were found, all equipment process parameters were observed to comply with standard requirements, and the adhesive used was within its validity period and meets the usage standard.Due to not receiving the actual sample, medline was not able to confirm what may have caused the issue.The cause is unconfirmed, sample required to determine cause, and 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: CLEARPRO,CLOSED SXN,14FR,D SWVL,ETT
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: abdul khan ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50946718
• Report Number: 1417592-2026-54321
• Device Sequence Number: 15836363
• Product Code: OFR
• UDI-Device Identifier: 10888277703384
• UDI-Public: 10888277703384
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• 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: DYNCPDS14
• Device Lot Number: 06925080011
• Was Device Available for Evaluation?: No
• 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: 02/09/2026
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/01/2025
• 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