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

Catalog Number	DYNCPDS14
Medical Device Problem Code	Decrease in Suction (1146)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/15/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the facility, "these catheters have been used on multiple patients with thick secretions, and the suction doesn't feel adequate.When you can hear the secretions, but the catheter doesn't seem to have adequate suction to remove them".The facility continued to state that they "have just continued to lavage with nacl if the secretions are thick, retest the suction tubing from the wall and attempt to suction again" and that "many have had a bronchoscope for secretion clearance, but are either still on the ventilator or stable".The facility stated there haven't been any dangerous situations to this point.It has been determined that the reported event could cause or contribute to serious injury if it were to occur.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
According to the facility, "these catheters have been used on multiple patients with thick secretions, and the suction doesn't feel adequate.When you can hear the secretions, but the catheter doesn't seem to have adequate suction to remove them".

• Common Device Name: CLEARPRO,CLOSED SXN,14FR,D SWVL,ETT
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: alex mathew ; three lakes drive; northfield, IL 60093-2753 ; 2249317042
• MDR Report Key: 21926930
• Report Number: 1417592-2025-00206
• Device Sequence Number: 15721649
• Product Code: BSY
• UDI-Device Identifier: 10888277703384
• UDI-Public: 10888277703384
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/29/2025

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
• Device Catalogue Number: DYNCPDS14
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2025
• Initial Report FDA Received Date: 04/29/2025
• 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 Sex: Unknown