MAUDE Adverse Event Report: BD MEDLINE; IV ADMIN SET,15DR,4NFPORTS,STPCOCK,109"

Catalog Number	DYNDTN1545D
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/16/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that tubing came disconnected at the manifold.Iv fluids ran out all over the floor and a small amount of blood back flowed to the floor: 1 inch puddle on floor.Iv tubing was put together by another staff member.Additional communication clarified that the disconnection occurred at the stopcock.The device was not used with a pressure bag or pump.
Event or Problem Description
Tubing disconnected.

• Brand Name: MEDLINE
• Common Device Name: IV ADMIN SET,15DR,4NFPORTS,STPCOCK,109"
• Manufacturer (Section D): BD
• Manufacturer Contact: lauren glaeser ; three lakes drive; northfield, IL 60093-2753
• MDR Report Key: 25184546
• Report Number: 1417592-2026-01298
• Device Sequence Number: 16026172
• Product Code: FPA
• UDI-Device Identifier: 10080196714933
• UDI-Public: 10080196714933
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K820278
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/15/2026

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: DYNDTN1545D
• Device Lot Number: 25125257
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/16/2026
• Supplement Date Received by Manufacturer: 05/18/2026
• Initial Report FDA Received Date: 05/15/2026
• Supplement Report FDA Received Date: 06/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/19/2025
• 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
• Patient Sex: Unknown