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

Catalog Number	2112351
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: during raw material inspection, two particulate matter embedded defects were located, causing a failure of raw material.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).Two (2) samples and two (2) photos were submitted to the manufacturer for evaluation.Through visual examination of the photos, particulate matter was observed.Through visual examination of the samples, it was possible to observe in one of the two bags a single embedded particle measuring approximately 0.2-0.3 mm, located in the same position identified in the complaint.The bags were then filled with saline solution and then filtered on a membrane in order to isolate any particles present in the fluid path.The results showed that the particle previously identified remained embedded into the eva material and did not detach.The other bag did not have any particles observed during visual inspection or after filtration.A review of the device history record (dhr) was performed for the reported lot number, and no abnormalities or non-conformance's were noted during the in process or final product inspection.Reserved samples with the same lot number were examined; no deviations or issues were observed.Based on the investigation, the reported issue was observed.The root cause of the issue is attributed to manufacturing of the eva tubular sheet.For the pinnacle bags involved in this case, since embedded particulate matter (pm) represents an aesthetic defect only and does not compromise the integrity or safety of the product, and given that no nonembedded complaints has been observed, no specific corrective actions will be initiated at this time.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: 23703850
• Report Number: 9681240-2025-00083
• Device Sequence Number: 10691599
• Product Code: KPE
• UDI-Device Identifier: 04046964200823
• UDI-Public: (01)04046964200823(11)230301(17)260227(10)23C03
• 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): 02/16/2026

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 Expiration Date: 02/27/2026
• Device Catalogue Number: 2112351
• Device Lot Number: 23C03
• 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: 11/05/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/03/2025
• Supplement Report FDA Received Date: 02/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2023
• 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