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

Catalog Number	2112349
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
As reported by the user facility: hi good morning, attaching the photos of our tpn with the plenamine added.They are slightly more yellow in person but not coming through in the photos.The bag on the left was the bag we compounded on (b)(6) and the bag on the right is the bag we compounded yesterday (b)(6).As more time passes, the bags seem to be getting slightly more yellow.
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).Four (4) photos were submitted to the manufacturer for evaluation.Through visual examination of the photos, it was observed that the solution of one of the bags is yellow.According to the complaint description, the bag in question was compounded the day prior to the comparison bag with no issues in the photo.Under review of these photos, no anomalies could be seen on the bag itself.A certain level of yellowing is noticeable, but this is due to the coloring of the solution inside which is reflected through the transparent film of the bag.Furthermore, the yellowish discoloration was observed once the bag had already been filled and not before; consequently, it is reasonable to assess that it results from a specific reaction within the solution which cannot be further evaluated from the bag side.Based on the available information, the reported condition was confirmed, but it is not possible to establish a clear root cause for the event.No product deviation could be fully attributable to the production process.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: PINNACLE®
• 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: 23756754
• Report Number: 9681240-2025-00087
• Device Sequence Number: 9521346
• Product Code: KPE
• UDI-Device Identifier: 04046964200700
• UDI-Public: (01)04046964200700
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 01/14/2026

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: 2112349
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/20/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/09/2025
• Supplement Report FDA Received Date: 01/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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