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

Catalog Number	415110
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	01/07/2025
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: brief inquiry description: leaking at connection point between ultrasite and ivc.Detailed inquiry description: when attaching the ultrasite to the iv catheter and secure it, blood starts pouring out of the site.So, ultimately it is not getting a good seal.They all look the same and we are unable to tell if it is ok until we try to lock it into the catheter.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).Three used samples were provided for evaluation.Upon visual inspection of the returned samples, the ultrasite valves were subject to a lure taper testing with passing results.The samples were leak tested with no leakage detected.The reported concern was unable to be confirmed.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.Five retains from the reported lot number were tested and passed per specification.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: ULTRASITE®
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 901 marcon blvd.; allentown PA 18109
• Manufacturer Contact: jonathan severino ; 901 marcon blvd.; allentown, PA 18109 ; 4847197287
• MDR Report Key: 21286726
• Report Number: 2523676-2025-00028
• Device Sequence Number: 18471482
• Product Code: FPA
• UDI-Device Identifier: 04022495769923
• UDI-Public: (01)04022495769923(11)240916(17)290831(10)0061960695
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K031923
• 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): 02/14/2025

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: 415110
• Device Lot Number: 0061960695
• 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: 01/09/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/31/2025
• Supplement Report FDA Received Date: 02/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/16/2024
• 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