MAUDE Adverse Event Report: BELMONT MEDICAL TECHNOLOGIES 3-SPIKE DISPOSABLE SET (1 PIECE); WARMER, THERMAL, INFUSION FLUID

Model Number	903-00006P
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Belmont tubing leaked from a specific part of the tubing, making it nonfuctional.

• Brand Name: 3-SPIKE DISPOSABLE SET (1 PIECE)
• Common Device Name: WARMER, THERMAL, INFUSION FLUID
• Manufacturer (Section D): BELMONT MEDICAL TECHNOLOGIES; 780 boston rd; billerica MA 01821
• MDR Report Key: 21605244
• Report Number: 21605244
• Device Sequence Number: 13125647
• Product Code: LGZ
• UDI-Device Identifier: 00896128002022
• UDI-Public: (01)00896128002022(17)271031(10)20241006
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 02/25/2025
• Report Date (Section F): 02/25/2025

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: 903-00006P
• Device Catalogue Number: 903-00006P
• Device Lot Number: 20241006
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 03/14/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/14/2025
• 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: 02/25/2025