MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. B.BRAUN; DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER)

Model Number	4555
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/30/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Registered nurse (rn) prepared to utilize dialysate bag for continuous renal replacement therapy (crrt) and noted that there was leaking coming from a crease in the plastic of the bag.This bag was set aside for risk management and another bag was selected.This bag was not utilized in patient care.

• Brand Name: B.BRAUN
• Common Device Name: DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER)
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 824 twelfth avenue; bethlehem PA 18018
• MDR Report Key: 19654808
• Report Number: 19654808
• Device Sequence Number: 6848225
• Product Code: KPO
• UDI-Device Identifier: 04046963330910
• UDI-Public: (01)04046963330910
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 04/24/2024
• Report Date (Section F): 04/24/2024

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
• Device Model Number: 4555
• Device Catalogue Number: 4555
• Device Lot Number: 2330293210
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 07/02/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/02/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 57 YR
• Patient Sex: Unknown
• Date Report Sent to FDA: 04/24/2024