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

Catalog Number	2112528
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
As reported by the user facility: description particulate matter identified during incoming aql inspection of received quantity of apex single chamber bag 250 ml lot 25c22.
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 manufacturing and testing procedures product was manufactured and released following acceptable testing in accordance with product procedures / work instructions.Verification of reserve samples no deviation was found.Sample investigation the customer submitted one video and one unused sterile container without its original packaging for direct inspection.A preliminary visual assessment confirmed the presence of foreign mobile particulate matter within the container, thereby confirming the customer complaint.A review of the production process at bai 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.Measure a review of the documentation provided by the customer was consistent with currently available findings.An approved project is in place to further address issues with foreign matter.

• 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: 25676811
• Report Number: 9681240-2026-00032
• Device Sequence Number: 11938977
• Product Code: KPE
• UDI-Device Identifier: 04046964539169
• UDI-Public: (01)04046964539169(11)250301(17)280228(10)25C22
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 07/01/2026

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: 2112528
• Device Lot Number: 25C22
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/08/2026
• Initial Report FDA Received Date: 07/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2025
• 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