MAUDE Adverse Event Report: BD SWITZERLAND SÀRL ALARIS; SET, I.V. FLUID TRANSFER

Model Number	MS3500-15
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/12/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Bd secondary tubing set (ref ms3500-15): the tubing broke away from the chamber allowing medication to spill out from bottom of chamber.

• Brand Name: ALARIS
• Common Device Name: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): BD SWITZERLAND SÀRL; 10020 pacific mesa blvd; san diego CA 92121
• MDR Report Key: 24686988
• Report Number: 24686988
• Device Sequence Number: 13262951
• Product Code: LHI
• UDI-Device Identifier: 10885403222610
• UDI-Public: (01)10885403222610
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 03/12/2026
• Report Date (Section F): 03/12/2026

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
• Operator of Device: Health Professional
• Device Model Number: MS3500-15
• Device Catalogue Number: MS3500-15
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 03/25/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/25/2026
• 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
• Date Report Sent to FDA: 03/12/2026