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

Model Number	552176
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/19/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Uneventful epidural placed for labor.After placement, unable to flush catheter.Catheter depth adjusted with no correction of problem.Catheter had to be removed, and new catheter placed.Nurse personally flushed the affected catheter.All three ports flushed without difficulty.Catheter will be returned to company for further evaluation.

• Brand Name: DESIGN OPTIONS®
• Common Device Name: EPIDURAL ANESTHESIA KIT
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 824 12th ave; bethlehem PA 18018
• MDR Report Key: 20343679
• Report Number: 20343679
• Device Sequence Number: 8055109
• Product Code: OGE
• UDI-Device Identifier: 04046955589487
• UDI-Public: (01)04046955589487
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/20/2024
• Report Date (Section F): 09/20/2024

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: 552176
• Device Catalogue Number: 552176
• Device Lot Number: 61920360
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 10/01/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/01/2024
• 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
• Patient Age: 29 YR
• Patient Sex: Female
• Date Report Sent to FDA: 09/20/2024