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

Catalog Number	SL-2000M2095D
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
Event or Problem Description
As reported by the user facility: event 4: we realized in a 2-3 day period that the whole system would fill with air only when the blood went into the lines.When it actually happened to two different patients on the same shift is when they realized that it probably was the lines so we pulled all that lot number which ended up being only a case (36) no.Patients involved: 5-6 date of incident: (b)(6) 2023.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).Event 4.The investigation is ongoing at this time.A follow-up will be submitted when the investigation results become available.
Additional Manufacturer Narrative
Event 4: this report has been identified as b.Braun medical internal report number (b)(4).No sample was returned for evaluation.The defect cannot be confirmed due to not having any evidence to support the reported incident.Since a sample was not returned for evaluation, the exact root cause of this incident could not be determined.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.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 18018 0027
• Manufacturer (Section G): B. BRAUN MEDICAL INC.; 824 12th avenue; bethlehem 18018 0027
• Manufacturer Contact: jonathan severino ; 901 marcon blvd; allentown, PA 18109 ; 4847197287
• MDR Report Key: 18475291
• Report Number: 2521402-2024-00004
• Device Sequence Number: 12486523
• Product Code: FJK
• UDI-Device Identifier: 04046955348763
• UDI-Public: (01)04046955348763
• Combination Product (Y/N): N
• Initial Reporter State: RI
• 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): 11/07/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/07/2026
• Device Catalogue Number: SL-2000M2095D
• Device Lot Number: A2300833
• 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: 01/03/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/09/2024
• Supplement Report FDA Received Date: 11/07/2024
• 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