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

Catalog Number	DYNCPDS14
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "suction catheter hub broken whilst on vent and during suctioning.".
Additional Manufacturer Narrative
The account reported finding "hub broken during suctioning." a sample was received and observed to be broken, confirming the complaint; the detachment was at the position between the s-shaped main body and the negative pressure connector.Device history record, incoming inspection, and shipping records were reviewed and found no similar abnormalities.The root cause could not be determined.No trends were found for this item, and in the event additional information becomes available this complaint will be reopened, updated, reevaluated, and investigated, as necessary.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.This 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 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: lauren glaeser ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50842496
• Report Number: 1417592-2026-46549
• Device Sequence Number: 18708033
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/18/2026

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 Catalogue Number: DYNCPDS14
• Device Lot Number: 06925080011
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/23/2026
• Is the Reporter a Health Professional?: Yes
• 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: 09/21/2026
• 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