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

Catalog Number	352636
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
As reported by the user facility: reason of complaint: customer reported b braun product #352636 leaking and tubing breaking apart at y-site connection.Rn said nursing staff didn't even pull-on tubing it just fell apart.The rn was preforming a flush following chemo treatment.No staff or patients were injured.
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.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).Sixteen (16) unused samples in sealed packaging were provided for evaluation.The samples were visually evaluated, and no disconnections were observed at any bonded joints.Thereafter, each sample was functional leakage tested, and all results were satisfactory.Based on the investigation findings, the samples 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: IV ADMINISTRATION SET
• 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: 23617229
• Report Number: 2521402-2025-01483
• Device Sequence Number: 18634769
• Product Code: FPA
• UDI-Device Identifier: 04046955594597
• UDI-Public: (01)04046955594597(11)250530(17)280530(10)0062007998
• 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): 12/30/2025

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: 352636
• Device Lot Number: 0062007998
• 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: 11/12/2025
• Supplement Date Received by Manufacturer: 11/12/2025
• Initial Report FDA Received Date: 11/21/2025
• Supplement Report FDA Received Date: 12/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/30/2025
• 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