MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. INFUSOMAT®; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	490102
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/05/2026
Type of Reportable Event	Malfunction
Event or Problem Description
As reported by the user facility: tubing appeared to be cut and was leaking fluid into pump.Drug used was decitabine and ns.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal number (b)(4).One used contaminated sample without packaging, and three photographs were submitted for evaluation.The sample was visually evaluated, and the tubing was found to be cut near the green clamp.The photographs were also reviewed, and one image shows the tubing cut in that same area near the green clamp.An exact root cause cannot be determined at this time.The most probable root cause of cut tubing is believed to be attributed to misloading of the iv set into the space pump.It should be noted the infusomat space pump manuals, iv blister lids, insert cards, as well as the space pump clearly indicates the correct instructions for loading the iv set into the space pump.All available information regarding this occurrence has been forwarded to the appropriate manufacturing business unit in order to heighten awareness.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.

• Brand Name: INFUSOMAT®
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 824 12th ave; bethlehem PA 18018
• Manufacturer (Section G): B. BRAUN MEDICAL INC.; 824 12th ave; bethlehem PA 18018
• Manufacturer Contact: elena reifenstein ; 824 12th ave; bethlehem, PA 18018 ; 8334251464
• MDR Report Key: 25594876
• Report Number: 2521402-2026-00627
• Device Sequence Number: 12123757
• Product Code: FPA
• UDI-Device Identifier: 04046964186127
• UDI-Public: (01)04046964186127(11)260225(17)290131(10)0062056312
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K142036
• 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): 06/23/2026

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
• Operator of Device: Health Professional
• Device Catalogue Number: 490102
• Device Lot Number: 0062056312
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/05/2026
• Initial Report FDA Received Date: 06/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/25/2026
• 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