MAUDE Adverse Event Report: B. BRAUN AVITUM ITALY S.P.A. 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)
Date of Event	07/21/2025
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
As reported by the b.Braun global affiliate: event 1: when did the failure occur: before application.Reason of complaint: presencia de contaminante (cabello).Presence of contaminant (hair).
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).Event 1 five (5) samples in original closed packaging and a photo were submitted to the manufacturer for evaluation.Through visual examination of the photo, a thin dark filament comparable to human hair was observed.Through visual examination of the samples, the presence of a human hair on the first bag was observed.The reported defect was observed; the complaint is considered confirmed.It was noted that the contamination is outside the product external to the fluid path.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.The defect is a result of a failure during the packaging phase.The production site meets clean room standard; hygiene regulations and rules of dressing are in place.The production department will be informed of this complaint and defect.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: jonathan severino ; 901 marcon blvd; allentown, PA 18109 ; 4847197287
• MDR Report Key: 22751618
• Report Number: 9681240-2025-00055
• Device Sequence Number: 15605119
• Product Code: KPE
• UDI-Device Identifier: 04046964200793
• UDI-Public: (01)04046964200793(11)241201(17)271130(10)24M02
• 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): 09/02/2025

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: 2112350
• Device Lot Number: 24M02
• 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: 07/21/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/08/2025
• Supplement Report FDA Received Date: 09/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2024
• 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