MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; CLEARPRO,CLOSED SXN,14FR,T-PC,ETT

Catalog Number	DYNCPTP14
Medical Device Problem Codes	Break (1069); Material Separation (1562); Gas/Air Leak (2946)
Health Effect - Clinical Code	Respiratory Insufficiency (4462)
Date of Event	07/17/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the customer, the suction catheters have been "breaking", "leaking", separating at the hinged elbow, the green band comes off around the sleeve, and they are "flimsy" causing difficulty when suctioning thick secretions.The customer reported when the issues arise, they are alerted due to the "ventilator alarming" and they replace the catheter, which then resolves the issue.The customer reported when the incident occurs it causes a "loss of volume" to the patients, but there has been no harm as a result of the reported issues.The customer did not report any serious injury, medical intervention, or follow up care related to the reported incident.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.
Event or Problem Description
According to the customer, the suction catheters have been "breaking", "leaking", separating at the hinged elbow, the green band comes off around the sleeve, and they are "flimsy" causing difficulty when suctioning thick secretions.

• Common Device Name: CLEARPRO,CLOSED SXN,14FR,T-PC,ETT
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: danielle tognocchi ; three lakes drive; northfield, IL 60093
• MDR Report Key: 22804621
• Report Number: 1417592-2025-00386
• Device Sequence Number: 7836899
• Product Code: BSY
• UDI-Device Identifier: 10888277703469
• UDI-Public: 10888277703469
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• 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): 08/14/2025

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: DYNCPTP14
• Device Lot Number: 06925030011
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2025
• Initial Report FDA Received Date: 08/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/01/2025
• 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