MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP MEDLINE; CLEARPRO,CLOSED SXN,12FR,T-PC,TRACH

Catalog Number	DYNCPTP12T
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Airway Obstruction (1699); Foreign Body In Patient (2687)
Date of Event	06/27/2026
Type of Reportable Event	Malfunction

• Brand Name: MEDLINE
• Common Device Name: CLEARPRO,CLOSED SXN,12FR,T-PC,TRACH
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: jessica walter ; three lakes drive; northfiled, IL 60093
• MDR Report Key: 25893445
• Report Number: 1417592-2026-07263
• Device Sequence Number: 18646231
• Product Code: OFR
• UDI-Device Identifier: 10888277703452
• UDI-Public: 10888277703452
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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
• Type of Report: Initial
• Report Date (Section B): 07/21/2026

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: Lay User/Patient
• Device Catalogue Number: DYNCPTP12T
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/29/2026
• Initial Report FDA Received Date: 07/21/2026
• 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 Age: 50 YR
• Patient Sex: Male
• Patient Weight: 104 KG