MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP CLEARPRO¿ TRACH T-PIECE CLOSED SUCTION CATHETER, 14 FRENCH; CLEARPRO,CLOSED SXN,14FR,T-PC,TRACH

Catalog Number	DYNCPTP14T
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/26/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Per report, "they are having difficulty putting the catheter down the trach and we are also experienced the ballard getting stuck on suction even though they released the suction port." customer also reported, "the suction catheter is resistant as you go down to suction invasively.Some of the ballards buttons are getting stuck down even though they are released.We are having to replace daily." 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 medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.
Event or Problem Description
Per report, "they are having difficulty putting the catheter down the trach and we are also experienced the ballard getting stuck on suction even though they released the suction port.".

• Brand Name: CLEARPRO¿ TRACH T-PIECE CLOSED SUCTION CATHETER, 14 FRENCH
• Common Device Name: CLEARPRO,CLOSED SXN,14FR,T-PC,TRACH
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: sipara semu ; three lakes drive; northfield, IL 60093-2753
• MDR Report Key: 25085704
• Report Number: 1417592-2026-00877
• Device Sequence Number: 10409187
• Product Code: OFR
• UDI-Device Identifier: 10888277703476
• UDI-Public: 10888277703476
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/23/2026

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: DYNCPTP14T
• Device Lot Number: 06924040011
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/05/2026
• Supplement Date Received by Manufacturer: 05/27/2026
• Initial Report FDA Received Date: 05/05/2026
• Supplement Report FDA Received Date: 06/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/05/2024
• 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
• Patient Sex: Unknown