MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP; CATH, CLOSED SUCTION, 14FR, DBL SWL, ETT

Catalog Number	DYNCSDS14
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	09/08/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the facility on 9/8/2024, "there was another sudden drop in vte and vti.The rt noticed that the inline suction catheter would not stay locked in the off position.The catheter was replaced, and the situation resolved.Rt saved the catheter and reported the event.He also confirmed the locking mechanism on the replacement catheter worked appropriately".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.Lots retained for investigation from customer: 28623040004, 28623040008, 28623070004, 28623080005, 28623090005, 28624020016.
Event or Problem Description
According to the facility on (b)(6) 2024, "there was another sudden drop in vte and vti.The rt noticed that the inline suction catheter would not stay locked in the off position.".

• Common Device Name: CATH, CLOSED SUCTION, 14FR, DBL SWL, 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: 20408322
• Report Number: 1417592-2024-00895
• Device Sequence Number: 15082500
• Product Code: BSY
• UDI-Device Identifier: 40884389125060
• UDI-Public: 40884389125060
• Combination Product (Y/N): N
• Initial Reporter State: MT
• 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): 10/09/2024

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: DYNCSDS14
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/11/2024
• Initial Report FDA Received Date: 10/09/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown