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

Catalog Number	2112341
Medical Device Problem Codes	Contamination /Decontamination Problem (2895); Device Contaminated During Manufacture or Shipping (2969)
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
Event 2 according to the complainant, black specks were found in the transfer set tubing and inside the plastic bag.No patient involvement.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).One (1) picture was provided for evaluation.Upon a visual inspection of the image provided, it was observed the presence of a dark spot in correspondence with the tubing, but it is not possible to determine whether the dot was inside or outside the tube, nor whether it is mobile or not.Another picture was received showing the pouch with the variable data and a last picture of the second sample showing a dark spot at one corner of the pouch.In this case, the spot was not in contact with the product.Based on the investigation results, the reported defect was confirmed.A review of the discrepancy management system (dsms) database was performed for the reported lot number and no abnormalities or non-conformances were noted during the in process or final product inspection.A batch record review for the reported lot number was performed, and no non-conformances or deviations were identified during the manufacturing process or final inspections.The retained sample corresponding to the reported lot number was visually and physically evaluated in accordance with the applicable specifications.All test results were found to be acceptable.As a result, the defect reported by the customer could not be confirmed in the retained sample.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: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): B. BRAUN AVITUM ITALY S.P.A.; via xxv luglio 11; mirandola, modena 41037 ; IT 41037
• Manufacturer (Section G): B. BRAUN MEDICAL INC.; 824 12th ave; bethlehem PA 18018
• Manufacturer Contact: elena reifenstein ; 901 marcon blvd; allentown, PA 18109 ; 8334251464
• MDR Report Key: 23335664
• Report Number: 2521402-2025-01218
• Device Sequence Number: 9461254
• Product Code: LHI
• UDI-Device Identifier: 04046964200229
• UDI-Public: (01)04046964200229(11)241101(17)291031(10)24L11
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K041222
• 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): 12/01/2025

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: 2112341
• Device Lot Number: 24L11
• 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: 10/01/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/20/2025
• Supplement Report FDA Received Date: 12/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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