MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. HEMODIALYSIS BLOODLINES; SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE

Catalog Number	SL-2000M2095
Medical Device Problem Code	Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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: event 1 issue #3: 2 bloodline letting air in the system which makes pulling saline through bloodlines very slow qty: 2 sample: no lot #: a2400097 injury: no.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).Event 1: a review of the device history record (dhr) was performed for the reported lot number and no abnormalities or nonconformances were noted during the in process or final product inspection.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.The reported defect was unable to be 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.

• Brand Name: HEMODIALYSIS BLOODLINES
• Common Device Name: SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE
• 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: jonathan severino ; 901 marcon blvd; allentown, PA 18109 ; 4847197287
• MDR Report Key: 20901548
• Report Number: 2521402-2024-00127
• Device Sequence Number: 15704671
• Product Code: FJK
• UDI-Device Identifier: 04046964367755
• UDI-Public: (01)04046964367755(17)270307(10)A2400097
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: K080807
• 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 Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/11/2025

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: SL-2000M2095
• Device Lot Number: A2400097
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/20/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/11/2024
• Supplement Report FDA Received Date: 03/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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