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

Catalog Number	SL-2010M2096
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: with this lot number, expires 4/7/28 the arterial line is getting a lot of air as soon as it is hooked up to the fistula or cvc (central venous line).There are air bubbles at that connection even though the user is making sure to lock the device in.The connection is not joining properly.As the devices were attached to a patient - none of the failing product is available for evaluation.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).No samples were provided for evaluation.Although no samples were provided, the reported event is similar to a known issue of air in line during use.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.The reported issue is due to a manufacturing issue with the arterial and venous patient connectors, which may allow air leakage resulting in microbubbles in the line, which could thus trigger air-in-line alarms.An approved project is in place to further address issues with air in line.Additionally, b.Braun medical inc.(bbmi) issued a voluntary urgent field safety correction for streamline® bloodline set for dialog+® hemodialysis system (2521402-9/3/25-004-c [z-0070-2026]).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: elena reifenstein ; 824 12th avenue; bethlehem, PA 18018 ; 8334251464
• MDR Report Key: 22666368
• Report Number: 2521402-2025-00266
• Device Sequence Number: 19758504
• Product Code: FJK
• UDI-Device Identifier: 04046964200670
• UDI-Public: (01)04046964200670(17)280407(10)A2500204
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 11/12/2025

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-2010M2096
• Device Lot Number: A2500204
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/30/2025
• Supplement Report FDA Received Date: 11/12/2025
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0070-2026
• Patient Sequence Number: 1
• Patient Sex: Unknown