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

Catalog Number	DYNCPDS14
Medical Device Problem Codes	Leak/Splash (1354); Suction Problem (2170)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/08/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the customer, on (b)(6) 2025, "the port to attach saline to the device to flush the line is not a snug fit, and therefore saline leaks on the patient" and that the provider had to switch to "open suctioning" due to "loss of primary function with leakage during use" to "avert airway compromise.".
Additional Manufacturer Narrative
According to the customer, on (b)(6) 2025, "the port to attach saline to the device to flush the line is not a snug fit, and therefore saline leaks on the patient" and that the provider had to switch to "open suctioning" due to "loss of primary function with leakage during use" to "avert airway compromise." no additional information is available at this time.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.

• Common Device Name: CLEARPRO,CLOSED SXN,14FR,D SWVL,ETT
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: jessica walter ; three lakes drive; northfield, IL 60093
• MDR Report Key: 23043028
• Report Number: 1417592-2025-00469
• Device Sequence Number: 9769257
• Product Code: OFR
• UDI-Device Identifier: 10888277703384
• UDI-Public: 10888277703384
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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
• Type of Report: Initial
• Report Date (Section B): 09/12/2025

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: DYNCPDS14
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/18/2025
• Initial Report FDA Received Date: 09/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Other
• Patient Sex: Unknown