MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. SAFEDAY¿; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	352635
Medical Device Problem Code	Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/05/2026
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: air in tubing line.The end user was evaluating this iv extension set design and reported that air is entering the line at the stopcock.Initially, they believed the issue was related to the dust cover on the stopcock, since their current baxter set uses a luer attachment and does not present this problem.No injury reported.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).Fifteen (15) unused samples in their original packaging were returned for evaluation.All samples underwent visual inspection, and no defects were identified.Each sample was also subjected to a leak test, with no leakage detected.It is important to note that, based on the event description indicating air ingress at the stopcock, the returned iv administration sets do not contain a stopcock component.Based on the evaluation results, the reported defect is not confirmed, and the products met internal specifications.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: SAFEDAY¿
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• 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: 24413273
• Report Number: 2521402-2026-00213
• Device Sequence Number: 21464410
• Product Code: FPA
• UDI-Device Identifier: 04046955594948
• UDI-Public: (01)04046955594948(11)240821(17)270821(10)0061958461
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K170595
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/05/2026

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: 352635
• Device Lot Number: 0061958461
• 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: 02/05/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/23/2026
• Supplement Report FDA Received Date: 03/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/21/2024
• 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