MAUDE Adverse Event Report: B. Braun Medical Inc. TX APEX¿; SYSTEM/DEVICE, PHARMACY COMPOUNDING

Catalog Number	601223
Medical Device Problem Code	Application Program Problem: Dose Calculation Error (1189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/11/2026
Type of Reportable Event	Malfunction
Event or Problem Description
As reported by the user facility: several source containers running dry during dispense.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).The investigation is ongoing at this time.A follow up will be submitted when the investigation results become available.

• Brand Name: APEX¿
• Common Device Name: SYSTEM/DEVICE, PHARMACY COMPOUNDING
• Manufacturer (Section D): B. Braun Medical Inc. TX; 1601 wallace drive; suite 150; carrollton TX 75006
• Manufacturer (Section G): B. Braun Medical Inc. TX; 1601 wallace drive; suite 150; carrollton TX 75006
• Manufacturer Contact: elena reifenstein ; 824 12th ave; bethlehem, PA 18018 ; +1(833)425-1464
• MDR Report Key: 50840785
• Report Number: 2521402-2026-00868
• Device Sequence Number: 10039740
• Product Code: NEP
• UDI-Device Identifier: 04046964801051
• UDI-Public: (01)04046964801051
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/21/2026

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: 601223
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/14/2026
• Initial Report FDA Received Date: 09/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• 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