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

Catalog Number	SL-2010M2096A
Medical Device Problem Code	Air/Gas in Device (4062)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	04/29/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).A 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.No samples or photos were submitted to the manufacturer for evaluation.Although no samples were provided, the reported event is similar to a known issue of air in line during use.The reported issue is due to a defect related to a tubing material change previously implemented.The change in tubing resin can lead to bubbles adhering to the inside of the arterial bloodline, in the segment between the patient connector and the blood pump.These bubbles are not being drawn into the bloodline from the external environment, but rather are the result of degassing of blood on the arterial side of the blood pump due to the high negative pressure within the tubing.With the previous tubing resin, these bubbles remained in the blood and were compressed or dissolved via the positive pressure applied post blood pump.With the new resin, these small bubbles adhere to the inside of the bloodline and may gather together to form larger bubbles.Further investigation of the issue is ongoing, and an action plan will be developed upon completion of the investigation.Urgent medical device correction 2521402-2/17/26-003-c [fda res # (b)(4)] was issued to inform users of the issue and provide information to reduce the risk.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.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).Event 5: seven pictures provided.The defect has been confirmed based on picture evaluation.The retains were visually and physically tested in accordance with specification requirements, and no failures or defects were identified.Retains passed internal testing.The implementation of the new dehp-free resin has been confirmed to contribute to the air bubble adhesion in the tubing, this change addresses air bubble adhesion observed in tubing following the implementation of a dehp free resin.The update is limited to design documentation only, with no bom or drawing changes at dr or suppliers at this time; existing sap controls.Required bom and drawing updates will be implemented through a future change control.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: 25192509
• Report Number: 2521402-2026-00514
• Device Sequence Number: 21352961
• Product Code: FJK
• UDI-Device Identifier: 04046955674992
• UDI-Public: (01)04046955674992(11)260320(17)290320(10)0062068536
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 05/27/2026

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-2010M2096A
• Device Lot Number: 0062068536
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/29/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/15/2026
• Supplement Report FDA Received Date: 05/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/20/2026
• 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