MAUDE Adverse Event Report: BD SWITZERLAND SARL ALARIS, SMARTSITE; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	20039E
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Rn placing iv preprocedural area.Rn tested the j-loop prior to iv insertion.J-loop would not flush/let saline pass through.A different j-loop that flushed was used for iv insertion.

• Brand Name: ALARIS, SMARTSITE
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BD SWITZERLAND SARL; 10020 pacific mesa blvd; san diego CA 92121
• MDR Report Key: 23485399
• Report Number: 23485399
• Device Sequence Number: 10329721
• Product Code: FPA
• UDI-Device Identifier: 07613203011952
• UDI-Public: (01)07613203011952
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 10/29/2025
• Report Date (Section F): 10/29/2025

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 Model Number: 20039E
• Device Catalogue Number: 20039E
• Device Lot Number: (10) 25075391
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 11/06/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/06/2025
• 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
• Date Report Sent to FDA: 10/29/2025