MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; CLEARPRO,CLOSED SXN,14FR,D SWVL,ETT

Catalog Number	DYNCPDS14
Medical Device Problem Codes	Unexpected Therapeutic Results (1631); Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Hypoxia (1918)
Date of Event	06/01/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the customer report, on (b)(6) 2025, during use of the device, a significant leak in the ventilator circuit during breath delivery was created.The patient experienced shortness of breath due to a ventilator leak during suctioning.
Additional Manufacturer Narrative
According to the customer report, on (b)(6) 2025, during use of the device, a significant leak in the ventilator circuit during breath delivery was created.The patient experienced shortness of breath due to a ventilator leak during suctioning.The clearpro suction catheter was removed and replaced with another brand, the patient was stable and experienced no further complications.The customer reported there was no serious injury, medical intervention, or follow-up care required 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.
Additional Manufacturer Narrative
Update to h6: type of investigation (b).

• Common Device Name: CLEARPRO,CLOSED SXN,14FR,D SWVL,ETT
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: jessica walter ; three lakes drive; northfield, IL 60093
• MDR Report Key: 22674570
• Report Number: 1417592-2025-00367
• Device Sequence Number: 7412230
• Product Code: BSY
• UDI-Device Identifier: 10888277703384
• UDI-Public: 10888277703384
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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,Followup
• Report Date (Section B): 08/22/2025

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: DYNCPDS14
• Device Lot Number: 06924070011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/03/2025
• Supplement Date Received by Manufacturer: 08/20/2025
• Initial Report FDA Received Date: 07/31/2025
• Supplement Report FDA Received Date: 08/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/05/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown