MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. B.BRAUN; SYSTEM/DEVICE, PHARMACY COMPOUNDING

Catalog Number	2112550
Medical Device Problem Code	Contamination of Device Ingredient or Reagent (2901)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/30/2024
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, (b)(6) called to report a defective transfer set that they observed fluid backing into the unused lines on the transfer set during production.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).One (1) used sample with packaging was provided for evaluation.The returned product was visually and functionally tested.The sample was tested for backflow on lines 5, 23, and 24.Each line was individually connected to a water source, allowing water to enter the lines with no backflow observed.The reported defect was not able to be replicated or confirmed.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.Note: the original initial mdr for this case was inadvertently submitted via the "test" account of the fda electronic submission gateway (esg) webtrader.As the original submission was not submitted through the "production" account of the fda esg webtrader, a new initial mdr submission is required per zoom call with sameer phanase of the fda esg help desk.

• Brand Name: B.BRAUN
• Common Device Name: SYSTEM/DEVICE, PHARMACY COMPOUNDING
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 901 marcon blvd; allentown PA 18109
• Manufacturer (Section G): B. BRAUN MEDICAL INC.; 901 marcon blvd; allentown PA 18109
• Manufacturer Contact: jonathan severino ; 901 marcon blvd.; allentown, PA 18109 ; 4847197287
• MDR Report Key: 20417014
• Report Number: 2523676-2024-00767
• Device Sequence Number: 8209627
• Product Code: NEP
• UDI-Device Identifier: 04046964656101
• UDI-Public: (01)04046964656101
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K151423
• 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): 10/10/2024

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: 04/30/2026
• Device Catalogue Number: 2112550
• Device Lot Number: 0061936887
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/30/2024
• Initial Report FDA Received Date: 10/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/07/2024
• 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