MAUDE Adverse Event Report: BLOOD ADMINISTRATION SET; SET, BLOOD TRANSFUSION

Model Number	V2500
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/18/2021
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: according to the report, there was a hair inside the tubing.No injury reported.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).Three (3) photographs were provided for evaluation.A visual evaluation was performed on the photographs and it was noted that a hair was found in the tubing.The customer provided an ftir analysis report confirming that the particulate is a natural polyamide, which is probably a hair fiber.Based on the visual evaluation of the photographs, the reported defect of particulate was confirmed.It should be noted that b.Braun products are manufactured under controlled conditions, and our assembly areas are stringently monitored for particulate contamination.B.Braun also has dedicated clean rooms and our garbing policy meets all gmp requirements.Contamination controls are in place to reduce the potential of contamination in controlled areas.This includes a requirement that all materials and equipment entering into the clean room must be passed through the designated material transfer room.Additionally, inspections and controls are currently in place during our in-process and final product inspections in order to inspect for and identify foreign contamination.Per in-process inspection procedure and per final product specification, personnel are required to inspect for foreign material on the product or in the package.No sample was provided for evaluation.Based on the data from the investigation we are unable to determine the root cause of the reported incident.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.We will maintain this report for further references and continue to monitor other reports for similar occurrences.

• Brand Name: BLOOD ADMINISTRATION SET
• Common Device Name: SET, BLOOD TRANSFUSION
• MDR Report Key: 12419047
• Report Number: 2523676-2021-00291
• Device Sequence Number: 1206833
• Product Code: BRZ
• UDI-Device Identifier: 04046964188633
• UDI-Public: 04046964188633
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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 faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/23/2021

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: 06/30/2023
• Device Model Number: V2500
• Device Catalogue Number: V2500
• Device Lot Number: 0061629306
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/26/2021
• Supplement Date Received by Manufacturer: 08/26/2021
• Initial Report FDA Received Date: 09/02/2021
• Supplement Report FDA Received Date: 10/23/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/17/2018
• 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