MAUDE Adverse Event Report: B. Braun Medical Inc. PINNACLE®; CONTAINER, I.V.

Catalog Number	2112350
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: i am just reaching out to let you guys know that we have stumbled upon our 3l tpn b-braun bags having blue fibers in them!.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number 400776926.One (1) photo was submitted to the manufacturer for evaluation.Through visual examination of the photo, a small, blue-colored particulate or fiber-like fragment placed on the surface of a white nonwoven wipe was observed.The particle appears elongated, irregular in shape, and blue in color.However, based on the photo alone, no further characteristics regarding the nature, composition, or dimensions of the particle can be confirmed.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.An in-depth review of the materials used in the manufacture of the aforementioned bag did not identify any raw material consistent with the color of the fiber observed.In the absence of additional information or a sample suitable for physicochemical analysis, its origin cannot be conclusively attributed to the manufacturing process.Based on the investigation, a blue fiber was observed in the provided photo.However, an exact root cause could not be determined 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 Medical Inc.; 824 12th avenue; bethlehem PA 18018
• Manufacturer (Section G): B. Braun Medical Inc.; 824 12th avenue; bethlehem PA 18018
• Manufacturer Contact: elena reifenstein ; 824 12th ave; bethlehem, PA 18018 ; +1(833)425-1464
• MDR Report Key: 50898562
• Report Number: 2521402-2026-00871
• Device Sequence Number: 6026564
• Product Code: KPE
• UDI-Device Identifier: 04046964200793
• UDI-Public: (01)04046964200793(11)251101(17)281030(10)25L25
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/25/2026

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: 2112350
• Device Lot Number: 25L25
• 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: 09/15/2026
• Initial Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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