MAUDE Adverse Event Report: B. BRAUN AVITUM ITALY S.P.A. APEX¿; CONTAINER, I.V.

Catalog Number	2112529
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).No samples or photos were submitted to the manufacturer for evaluation.Through visual examination of reserved samples, no deviations or issues were observed.A review of the device history record (dhr) was performed for the reported lot number, and no abnormalities or non-conformances were noted during the in process or final product inspection.Based on the investigation, the reported issue could not be observed.However, the reported event is consistent with previously observed cases and available evidence.As part of the continuous quality improvement process, an approved project is in place to further address issues with foreign matter.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: during raw material inspection, 1 unit was identified to have particulate matter - mobile.

• Brand Name: APEX¿
• Common Device Name: CONTAINER, I.V.
• Manufacturer (Section D): B. BRAUN AVITUM ITALY S.P.A.; via xxv luglio 11; mirandola, 41037 ; IT 41037
• Manufacturer (Section G): B. BRAUN AVITUM ITALY S.P.A.; via xxv luglio 11; mirandola, 41037 ; IT 41037
• Manufacturer Contact: elena reifenstein ; 824 12th ave; bethlehem, PA 18018 ; 8334251464
• MDR Report Key: 25736954
• Report Number: 9681240-2026-00035
• Device Sequence Number: 10554131
• Product Code: KPE
• UDI-Device Identifier: 04046964539121
• UDI-Public: (01)04046964539121(11)250401(17)280330(10)25D22
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K041415
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/07/2026

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: 2112529
• Device Lot Number: 25D22
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/24/2026
• Initial Report FDA Received Date: 07/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/01/2025
• 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