MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP MEDLINE; CLEARPRO,CLOSED SXN,14FR,D SWVL,TRAC

Catalog Number	DYNCPDS14T
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/06/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
According to the facility on 2/06/26, "while suctioning, the hub of the catheter broke off and lodged in the vent circuit.The respiratory therapist needed to use forceps to retrieve the broken piece before it reached the patient." 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 medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.
Event or Problem Description
According to the facility on 2/06/26, "while suctioning, the hub of the catheter broke off and lodged in the vent circuit.The respiratory therapist needed to use forceps to retrieve the broken piece before it reached the patient.".
Additional Manufacturer Narrative
Update to h6.After further investigation, it has been determined that the investigation involved testing of the actual/suspected device, trend analysis, and analysis of production records.A malfunction was observed without a conclusive finding, and the cause remains unestablished.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

• Brand Name: MEDLINE
• Common Device Name: CLEARPRO,CLOSED SXN,14FR,D SWVL,TRAC
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes dr; northfield IL 60093 2753
• Manufacturer Contact: gavin-ainsley nadong ; three lakes dr; northfield, IL 60093-2753
• MDR Report Key: 24568373
• Report Number: 1417592-2026-00208
• Device Sequence Number: 21222787
• Product Code: OFR
• UDI-Device Identifier: 10888277703391
• UDI-Public: 10888277703391
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/06/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: DYNCPDS14T
• Device Lot Number: 06924100011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/11/2026
• Supplement Date Received by Manufacturer: 03/24/2026
• Initial Report FDA Received Date: 03/11/2026
• Supplement Report FDA Received Date: 04/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/05/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown