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	04/21/2025
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
According to the event description: during the parenteral nutrition quality check, a stain was identified on the parenteral nutrition bag at the port for connection of the administration equipment.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).One (1) sample was submitted to the manufacturer for evaluation.Through visual examination, a dark particle embedded in the bonding area between the infusion port body and the tubing was observed.The particle was not movable and not in contact with the fluid path.The functioning of the product is not jeopardized; the defect is considered aesthetic.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.The component is assembled on the bag through an automatic machine; the defective bag was not recognized and segregated in the following inspection step.The manufacturing personnel involved in assembly and inspection process was informed of this complaint.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.; 11 via xxv luglio; mirandola, modena 41037 ; IT 41037
• Manufacturer (Section G): B. BRAUN AVITUM ITALY S.P.A.; 11 via xxv luglio; mirandola, modena 41037 ; IT 41037
• Manufacturer Contact: jonathan severino ; 901 marcon blvd.; allentown, PA 18109 ; 4847197287
• MDR Report Key: 22077441
• Report Number: 9681240-2025-00050
• Device Sequence Number: 9363586
• Product Code: KPE
• UDI-Device Identifier: 04046964200700
• UDI-Public: (01)04046964200700(11)241101(17)271031(10)24L29
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/18/2025

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
• Device Catalogue Number: 2112349
• Device Lot Number: 24L29
• 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: 04/21/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/23/2025
• Supplement Report FDA Received Date: 06/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2024
• 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