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

Catalog Number	2112530
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 were submitted to the manufacturer, because a destructive ftir spectroscopic analysis on the tpn apex bags were performed on the user's end.A ftir analysis report covering four bags, each containing mobile particle matter (pm) was provided.Of the four inspected bags, there contained natural pm, identified as cellulose or cotton fibers, while one contained synthetic pm identified as cellulose.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.Through examination of reserved samples, no deviations were observed.A review of the production process confirmed that no changes had been made to the bag materials, manufacturing process, or quality control activities.Furthermore, no deviations or anomalies were recorded in the relevant production batches that could account for the reported issue.Based on the investigation, a direct investigation could not confirm the presence of pm in the affected bags as no samples were sent in.However, the report provided by the user facility and the analysis performed are consistent with the customer's findings.An exact root cause for the reported issue could not be determined, but 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: some of these units were used in production and found to have 1 particulate matter - solution.

• 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 ; 901 marcon blvd; allentown, PA 18109 ; 4847197287
• MDR Report Key: 25141637
• Report Number: 9681240-2026-00028
• Device Sequence Number: 9453528
• Product Code: KPE
• UDI-Device Identifier: 04046964539183
• UDI-Public: (01)04046964539183(11)250101(17)271231(10)25A25
• 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): 05/11/2026

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: 2112530
• Device Lot Number: 25A25
• 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: 04/16/2026
• Initial Report FDA Received Date: 05/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/01/2025
• 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