MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. IV ADMINISTRATION SET; STOPCOCK, I.V. SET

Model Number	490432
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/23/2025
Type of Reportable Event	Malfunction
Event or Problem Description
When the package was opened, set was discovered to be in 2 pieces like it was cut.

• Brand Name: IV ADMINISTRATION SET
• Common Device Name: STOPCOCK, I.V. SET
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 824 twelfth avenue; bethlehem PA 18018
• MDR Report Key: 23778784
• Report Number: 23778784
• Device Sequence Number: 21330254
• Product Code: FMG
• UDI-Device Identifier: 04046964832819
• UDI-Public: (01)04046964832819(17)280430100062005332
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 10/24/2025
• Report Date (Section F): 10/24/2025

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: 490432
• Device Catalogue Number: 490432
• Device Lot Number: 0062005332
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Ambulatory Surgical Facility
• Date Report to Manufacturer: 12/11/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/11/2025
• 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: 10/24/2025