MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. Design Options®; Epidural anesthesia kit

Model Number	552116
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/08/2026
Type of Reportable Event	Malfunction
Event or Problem Description
When opening an epidural kit, a hair was noticed under the gauze and on the sterile drape.The kit was closed and the patient did not come in contact with it.A new kit was obtained, and the patient was prepped and draped.Epidural was placed without incident.The contaminated kit was saved for reporting.No pt harm.

• Brand Name: Design Options®
• Common Device Name: Epidural anesthesia kit
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 824 twelfth avenue; bethlehem PA 18018
• MDR Report Key: 50817653
• Report Number: 50817653
• Device Sequence Number: 21371884
• Product Code: OGE
• UDI-Device Identifier: 04046964950247
• UDI-Public: (01)04046964950247
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 09/10/2026
• Report Date (Section F): 09/10/2026

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 Model Number: 552116
• Device Catalogue Number: 552116
• Device Lot Number: 0062061735
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 09/18/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/18/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female
• Patient Weight: 227 LB
• Date Report Sent to FDA: 09/10/2026