MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. DISCOFIX®; ACCESSORIES, CATHETER

Catalog Number	456020
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Convulsion/Seizure (4406)
Date of Event	07/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
As reported by the user facility: detailed inquiry description: stopcock leaked at the connection to the iv line.Description of the patient event: customer states that due to the infusion of propofol not being administered because of the leak, the patient ended up having a seizure.
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).Two (2) used samples without packaging were provided for investigation.Upon evaluation of the samples, lure taper testing was performed prior to the samples being connected to a water pressure source.Pressure was applied at 80 psi for 10 seconds.The pressure was reduced to 0 psi, fully opening all ports.The procedure was repeated, and 80 psi was applied for an additional 10 seconds.Leakage was not observed throughout the testing process.The reported issue was unable to be confirmed.All information concerning this reported incident has been included in our trend analysis of the product line.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.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: DISCOFIX®
• Common Device Name: ACCESSORIES, CATHETER
• 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: jonathan severino ; 901 marcon blvd.; allentown, PA 18109 ; 4847197287
• MDR Report Key: 22529641
• Report Number: 2521402-2025-00243
• Device Sequence Number: 7932106
• Product Code: KGZ
• UDI-Device Identifier: 04046964996962
• UDI-Public: (01)04046964996962(11)250505(17)280201(10)25B18D9004
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K760383
• 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): 08/26/2025

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: 456020
• Device Lot Number: 25B18D9004
• 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: 07/09/2025
• Supplement Date Received by Manufacturer: 07/15/2025
• Initial Report FDA Received Date: 07/17/2025
• Supplement Report FDA Received Date: 08/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/05/2025
• 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