MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; IV ADMIN SET, 15DRP, 3 NF PORTS, 112"

Catalog Number	DYNDST1545
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/28/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
According to the customer, "the distal port on the the iv tubing leaks at times.I'm not sure if the valve gets stuck or what.I always use the 60 in extension tubing and place on distal port with propofol running.Some times it leaks, sometimes it doesn't.Once the leak is noticed the extension tubing is placed on a different port until the case is over".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 customer, "the distal port on the the iv tubing leaks at times.".

• Common Device Name: IV ADMIN SET, 15DRP, 3 NF PORTS, 112"
• 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: 19181674
• Report Number: 1417592-2024-00547
• Device Sequence Number: 7147446
• Product Code: FPA
• UDI-Device Identifier: 20884389975968
• UDI-Public: 20884389975968
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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): 04/25/2024

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
• Device Catalogue Number: DYNDST1545
• Device Lot Number: 760853441
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/28/2024
• Initial Report FDA Received Date: 04/25/2024
• 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
• Patient Sex: Unknown