MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. DESIGN OPTIONS®; EPIDURAL ANESTHESIA KIT

Catalog Number	552116
Medical Device Problem Codes	Break (1069); Difficult to Advance (2920)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/19/2025
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: catheter shearing.Detailed inquiry description upon catheter removal the catheter appeared sheared, and tip is missing.No injury reported.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).One (1) photograph was provided for investigation.Upon evaluation of the picture, one catheter was observed to be coiled and not damaged.The second catheter photographed was noted to be contaminated, used and had been sheared with the coil exposed and frayed.The reported concern was not confirmed to be result of any manufacturing process.Based on the data from the investigation, the reported defect 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.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: DESIGN OPTIONS®
• Common Device Name: EPIDURAL ANESTHESIA KIT
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 901 marcon blvd.; allentown PA 18109
• Manufacturer Contact: jonathan severino ; 824 12th ave; bethlehem, PA 18018 ; 4847197287
• MDR Report Key: 22005515
• Report Number: 2523676-2025-00465
• Device Sequence Number: 21107127
• Product Code: OGE
• UDI-Device Identifier: 04046964950254
• UDI-Public: (01)04046964950254
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• 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): 07/31/2025

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: 552116
• 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: 04/20/2025
• Supplement Date Received by Manufacturer: 05/08/2025
• Initial Report FDA Received Date: 05/12/2025
• Supplement Report FDA Received Date: 07/31/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 32 YR
• Patient Sex: Female
• Patient Weight: 78 KG
• Patient Race: White