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
Event or Problem Description
As reported by the user facility: we have a package of 1000ml apex bags that have a contaminant in them.I think it may be a bug or some dirt?.
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).Five (5) samples and two (2) photos were submitted to the manufacturer for evaluation.Through visual examination of the photos, an enlargement of the non-reopening clamp assembled on the infusion tube had a dark spot on its surface.The reported issue is observed.Through visual examination of the samples, the same dark spot was observed on the sample specifically on the non-reopening clamp; thus, the contaminant is not in contact with the fluid path.No anomalies were found in the rest of the bag.The dark spot is embedded in the wall and its formation can be linked to the molding phase of the component.The components used to produce the bag are purchased from an approved supplier and statistically inspected during incoming of the product.No deviations were found in process and at the incoming.Therefore, it is believed that this is an isolated issue.In addition, the spot is made by the same material of the component; the functioning of the product is not jeopardized, and the defect is classified as aesthetic.The supplier of the component has been informed of this complaint and all personnel involved in the assembly phase and control have also been informed.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.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: jonathan severino ; 901 marcon blvd; allentown, PA 18109 ; 4847197287
• MDR Report Key: 22895205
• Report Number: 9681240-2025-00061
• Device Sequence Number: 8957728
• Product Code: KPE
• UDI-Device Identifier: 04046964539183
• UDI-Public: (01)04046964539183(11)250101(17)271231(10)25A28
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 10/30/2025

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: 25A28
• 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: 08/05/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/26/2025
• Supplement Report FDA Received Date: 10/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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