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

Model Number	24010-0007T
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/12/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Patient noticed wet feeling on skin.Upon rn's investigation, chemo tubing was leaking above green cap.Pre-hydration only, no chemo spill.Texium is bonded onto tubing.Leaking was noted where the texium is bonded onto the straight set.This was a one time issue.Have not heard of other issues from this lot or related to bonded texium.

• Brand Name: ALARIS, SMARTSITE, TEXIUM
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BD SWITZERLAND SARL; 10020 pacific mesa blvd; san diego CA 92121
• MDR Report Key: 24469234
• Report Number: 24469234
• Device Sequence Number: 21227754
• Product Code: FPA
• UDI-Device Identifier: 10885403271021
• UDI-Public: (01)10885403271021
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/23/2026
• Report Date (Section F): 02/23/2026

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 Model Number: 24010-0007T
• Device Catalogue Number: 24010-0007T
• Device Lot Number: (10)25045192
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 02/27/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/27/2026
• 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 Age: 13 YR
• Patient Sex: Male
• Date Report Sent to FDA: 02/23/2026