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

Model Number	552155
Health Effect - Clinical Code	Pain (1994)
Date of Event	03/22/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Patient called out stating that she was in pain and the epidural was not working; rn (registered nurse) found the epidural catheter tubing to be disconnected from the alligator clip and was infusing into the floor.Rn consulted anesthesia immediately and md sterilely cut and reclamped epidural catheter.Patient was rebolused at that time.

• 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: 19104273
• Report Number: 19104273
• Device Sequence Number: 7737473
• Product Code: OGE
• UDI-Device Identifier: 04046955243051
• UDI-Public: (01)04046955243051
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 03/25/2024
• Report Date (Section F): 03/25/2024

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
• Device Model Number: 552155
• Device Catalogue Number: 552155
• Device Lot Number: 0061903526
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 04/15/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/15/2024
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 1 MO
• Patient Sex: Female
• Patient Weight: 121 KG
• Patient Race: White
• Date Report Sent to FDA: 03/25/2024