MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. ADDEASE®; SET, I.V. FLUID TRANSFER

Catalog Number	BC2000
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).One (1) used binary connectors attached to unknown drug vial and pab bag without packaging was returned for evaluation.The fully assembled and activated addease system was visually inspected and no defects were observed.Additionally, the system was disassembled and subjected to further visual examination, during which the presence of a black particle defect on the binary connector could not be detected.Based on the results of the evaluation the defect reported was not confirmed.We will maintain this report for further references and continue to monitor other reports for similar occurrences.If any additional pertinent information becomes available, a follow up will be submitted.
Event or Problem Description
As reported by the user facility: brief inquiry description: black particle found in addease assembly.Detailed inquiry description: rn when to activate addease assembly but found a black speck on the white rubber plug from the addease.The black speck did not come off the white rubber plug, but when i shook the assembly, it then removed itself from the white plug.The black speck is still in the assembly unit, but it's no longer visible.It is stuck somewhere in the system.

• Brand Name: ADDEASE®
• Common Device Name: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 901 marcon blvd.; allentown PA 18109
• Manufacturer Contact: jonathan severino ; 901 marcon blvd.; allentown, PA 18109 ; 4847197287
• MDR Report Key: 21961383
• Report Number: 2523676-2025-00425
• Device Sequence Number: 20649470
• Product Code: LHI
• UDI-Device Identifier: 04046964186592
• UDI-Public: (01)04046964186592
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• PMA/510(K) Number: K090905
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/05/2025

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
• Operator of Device: Health Professional
• Device Catalogue Number: BC2000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/12/2025
• Initial Report FDA Received Date: 05/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown