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

Catalog Number	2112531
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).The investigation is ongoing at this time.A follow-up will be submitted when the investigation results become available.
Event or Problem Description
As reported by the user facility: we have added another lot of raw material to scar-01725 for apex 2000 ml single chamber bags.During raw material inspection, one particulate was found in solution, a white flake, causing a failure of raw material.Nc-12145 has been initiated.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).One sample and one photo from lot # 25b12 were submitted to the manufacturer for evaluation.Through visual examination of the photo, particulate matter was observed.For lot # 25b12, initially the particle could not be detected.The bag was filled with saline solution and then filtered on a membrane.One particle measuring approximately 1 mm was isolated and analyzed with the support of the chemical laboratory, and an ftir analysis was performed.The results showed that the particle is composed of abs (acrylonitrile butadiene styrene).This material is used to make the fl connector built on the bag.This component is purchased from an approved supplier and statistically inspected during incoming.A review of the device history record (dhr) was performed for the reported lot numbers, and no abnormalities or non-conformances were noted during the in process or final product inspection.Under review of the production process, no changes have been made to the bag materials, process, or the quality controls.No deviations or anomalies were recorded in the relevant production batches that could explain the issue.Based on the investigation, the reported issue was observed; however, an exact root cause could not be determined at this time.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.

• 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: 23536105
• Report Number: 9681240-2025-00068
• Device Sequence Number: 10167779
• Product Code: KPE
• UDI-Device Identifier: 04046964539206
• UDI-Public: (01)04046964539206(11)250201(17)280131(10)25B12
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/10/2026

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: 2112531
• Device Lot Number: 25B12
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/22/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/12/2025
• Supplement Report FDA Received Date: 02/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2025
• 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