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

Catalog Number	2112348
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: a small particulate was identified in a certain lot of pinnacle 1l bags.No injury reported.
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).Two (2) samples were submitted to the manufacturer for evaluation.Through visual examination, it was possible to detect a foreign plastic-like object in each of the bags provided.Each of the samples were filled with saline solutions and subsequently filtered.The results after analysis assessed for each bag the presence of a eva particle.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.Reserved samples were examined; no deviations or abnormalities were observed.Based on the investigation, the reported issue was observed.A detailed review of the manufacturing process, in-process controls, and production records was conducted.No documented deviations, process changes, or anomalies were identified for the affected batch.The evidence suggests that the foreign particles originated during the manufacturing phase.Therefore, the most probable root cause is identified as an isolated production oversight.The production department will be informed, and contamination prevention practices as well as operator awareness during manufacturing and handling activities are reinforced.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: 24482225
• Report Number: 9681240-2026-00002
• Device Sequence Number: 10331918
• Product Code: KPE
• UDI-Device Identifier: 04046964200670
• UDI-Public: (01)04046964200670(11)251101(17)281030(10)25L07
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 04/29/2026

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
• Device Catalogue Number: 2112348
• Device Lot Number: 25L07
• 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: 02/17/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/02/2026
• Supplement Report FDA Received Date: 04/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2025
• 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