MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP; IV EXT SET,SMBORE EXT,8,M LUERLOCK,1NF

Catalog Number	DYNDTB5081
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Medication dripped out of the extension set.
Additional Manufacturer Narrative
It was reported that during adminstration of medication, the liquid began "dripping out of the connection".No serious injury was reported related to this incident.In an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained,.
Additional Manufacturer Narrative
Updated sections d9, g3, g6, h2, h3, h6.

• Common Device Name: IV EXT SET,SMBORE EXT,8,M LUERLOCK,1NF
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: kelly zampella ; three lakes drive; northfield, IL 60093
• MDR Report Key: 23757191
• Report Number: 1417592-2025-00691
• Device Sequence Number: 10079394
• Product Code: FPA
• UDI-Device Identifier: 10197344098668
• UDI-Public: 10197344098668
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K242126
• 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): 12/29/2025

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?: Yes
• Device Expiration Date: 04/01/2023
• Device Catalogue Number: DYNDTB5081
• Device Lot Number: BQ250456501
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/13/2025
• Supplement Date Received by Manufacturer: 12/19/2025
• Initial Report FDA Received Date: 12/09/2025
• Supplement Report FDA Received Date: 12/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2025
• 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 Age: 69 YR
• Patient Sex: Female
• Patient Weight: 78 KG