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

Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/31/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Update to annex codes b, c, d.Update to h3.Update to h11 verbiage.
Event or Problem Description
Per report, " the suction catheter came a part while being attached to the patient for less than 12 hours.".
Additional Manufacturer Narrative
Per report, " the suction catheter came a part while being attached to the patient for less than 12 hours." 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.

• Brand Name: CLEARPRO¿ TRACH T-PIECE CLOSED SUCTION CATHETER, 14 FRENCH
• Common Device Name: CLEARPRO,CLOSED SXN,14FR,T-PC,ETT
• 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: 25061037
• Report Number: 1417592-2026-00787
• Device Sequence Number: 9400092
• Product Code: OFR
• UDI-Device Identifier: 10888277703469
• UDI-Public: 10888277703469
• Combination Product (Y/N): N
• Initial Reporter State: NE
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/28/2026

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
• 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: 04/01/2026
• Supplement Date Received by Manufacturer: 04/27/2026
• Initial Report FDA Received Date: 05/01/2026
• Supplement Report FDA Received Date: 05/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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