MAUDE Adverse Event Report: Medline Industries, LP Medline; CLEARPRO,CLOSED SXN,14FR,T-PC,TRACH

Catalog Number	DYNCPTP14T
Medical Device Problem Codes	Break (1069); Leak/Splash (1354); Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/16/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The report states, "this suction ballard was in use on a trach patient.The rt found it on a patient with a leak and upon inspection, it broke off.".
Additional Manufacturer Narrative
The report states, "this suction ballard was in use on a trach patient.The rt found it on a patient with a leak and upon inspection, it broke off." customer also reported, "caregiver was in the process of suctioning the patient via trach suction ballard and the suction ballard broke off.Trach suction ballard was immediately change out to a new one." 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: Medline
• Common Device Name: CLEARPRO,CLOSED SXN,14FR,T-PC,TRACH
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: sipara semu ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50203689
• Report Number: 1417592-2026-08487
• Device Sequence Number: 13371270
• Product Code: OFR
• UDI-Device Identifier: 10888277703476
• UDI-Public: 10888277703476
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 08/11/2026

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
• Operator of Device: Other
• Device Catalogue Number: DYNCPTP14T
• Device Lot Number: 06924070011
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/16/2026
• Initial Report FDA Received Date: 08/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/01/2024
• 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: Male