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

Model Number	20038E
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Low Blood Pressure/ Hypotension (1914)
Date of Event	10/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
While turning the patient, there was a significant drop in the patient's blood pressure.This required emergent actions, and the physicians were notified and brought to bedside.Medications were administered and were titrated to increase the patient's blood pressure.While placing a backboard underneath the patient, blood was discovered under the patient's back.Upon further investigation, it was found that the iv tubing connected to the patient's rij [right internal jugular] cordis was severed.The medications the patient was receiving to maintain their blood pressure were administered through this line.Due to the disconnection, the patient was not receiving the medications and experienced blood loss from the severed line as well.The severed iv tubing was promptly replaced.

• Brand Name: ALARIS, SMARTSITE
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BD SWITZERLAND SÀRL; 10020 pacific mesa blve; san diego CA 92121
• MDR Report Key: 23485235
• Report Number: 23485235
• Device Sequence Number: 10559105
• Product Code: FPA
• UDI-Device Identifier: 07613203011976
• UDI-Public: (01)07613203011976
• 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): 10/22/2025
• Report Date (Section F): 10/22/2025

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: 20038E
• Device Catalogue Number: 20038E
• Device Lot Number: (10)25075326
• 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 Age: 52 YR
• Patient Sex: Male
• Date Report Sent to FDA: 10/22/2025