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
Event or Problem Description
The complainant reports that the injection port is contaminated.No patient complications were reported as a result of this event.
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.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).One (1) sample and two (2) photos were submitted to the manufacturer for evaluation.Through visual examination, the presence of a dark particle was observed embedded in the bonding area between the injection port and the tubing.The size of the particle was approximately 2 mm.The particle is not movable and is not in contact with the fluid path.Therefore, the functionality of the product is not jeopardized.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 visual examination of reserved samples, no deviations were observed.The component is assembled on the bag through an automatic machine; the complaint product was not recognized and segregated in the following inspection step.The personnel involved in the assembly and inspection process were informed of this complaint to heighten awareness of this defect.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: 24257236
• Report Number: 9681240-2026-00091
• Device Sequence Number: 20910340
• Product Code: KPE
• UDI-Device Identifier: 04046964539220
• UDI-Public: (01)04046964539220(11)250601(17)280530(10)25F17
• 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): Unknown
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/26/2026

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: 25F17
• 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: 01/12/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/04/2026
• Supplement Report FDA Received Date: 02/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2025
• 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