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

Catalog Number	2112532
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).Review of device history record no deviation was found in device history record.Verification of reserve samples no deviation was found.Sample investigation the customer provided one unused, non-contaminated unit, lacking its original primary packaging, for direct evaluation.Visual inspection confirmed the presence of a white speck, approximately 1 mm in diameter, located on the inner surface of the apex container.The anomaly generated a slight tactile protrusion, thereby corroborating the reported complaint.To further characterize the defect, the unit was filled with saline solution.Upon filling, the speck separated into two distinct portions, each adhering to the apex flaps, thereby confirming its presence within the fluid path.Detailed examination indicated that the material is consistent with a silicone residue.The most probable root cause is a residual from the tubing extrusion process that remained embedded within the apex container fluid path.Due to its characteristics and limited detectability, the contamination was not identified nor removed during subsequent in-process inspection and control stages.Measure the production department will be formally notified to reinforce awareness and diligence regarding in-process inspection controls, with specific emphasis on the identification and segregation of non-conforming products.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: i have 1 apex eva mixing container 3 liter bag and it has a white foreign matter inside the bag and i would like to report that issue.

• 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: 25563841
• Report Number: 9681240-2026-00031
• Device Sequence Number: 15971885
• Product Code: KPE
• UDI-Device Identifier: 04046964539220
• UDI-Public: (01)04046964539220(11)250701(17)280629(10)25G29
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 06/19/2026

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: 2112532
• Device Lot Number: 25G29
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/28/2026
• Initial Report FDA Received Date: 06/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2025
• 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