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

Catalog Number	SL-2000M2095DA
Medical Device Problem Codes	Device Alarm System (1012); Air/Gas in Device (4062)
Health Effect - Clinical Code	Embolism/Embolus (4438)
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: we have several lots over the last 8 weeks that have had air in the line (air in line post needle connection to pre dialyzer) that triggers the machine system to alarm, venous pressure to become erratic causing disruption in treatment and clotting.No injury reported.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).One (1) unused sample in original packaging was provided for evaluation.The sample underwent visual inspection and no defects were detected.An occlusion test was performed, and the results showed no failures.Thereafter, the sample was subjected to leakage test in accordance with the design input requirements by creating a closed system between the arterial and venous sections of the sets and evaluating them using air underwater method.The results indicated no failures.Based on the investigation findings, the sample met internal specification; therefore, the reported defect was not confirmed.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.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 ave; bethlehem PA 18018
• Manufacturer (Section G): B. BRAUN MEDICAL INC.; 824 12th ave; bethlehem PA 18018
• Manufacturer Contact: elena reifenstein ; 824 12th ave; bethlehem, PA 18018 ; 8334251464
• MDR Report Key: 24389223
• Report Number: 2521402-2026-00175
• Device Sequence Number: 10622667
• Product Code: FJK
• UDI-Device Identifier: 04046955776023
• UDI-Public: (01)04046955776023(11)251209(17)281209(10)00VL050591
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 02/25/2026

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-2000M2095DA
• Device Lot Number: 00VL050591
• 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: 01/30/2026
• Supplement Date Received by Manufacturer: 01/30/2026
• Initial Report FDA Received Date: 02/19/2026
• Supplement Report FDA Received Date: 02/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/09/2025
• 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