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	03/05/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Four reports: (all with different provider insertions).Patient had an epidural that had previously been working well.She then began complaining of increased pain and pressure.Rn (registered nurse) assisted patient with position change and noticed a wet spot on the sheet under the patient.Rn noticed the epidural catheter was disconnected from the alligator clip and lying the bed.Patient reported hearing a pop on her back.The white cap had disconnected from the line going to the patient.Fluid leaking from the patient.Epidural was taken out and replaced.Patient¿s epidural catheter disconnected by tearing near the hub where it connects from the pump to patient.Insertion site was intact.Anesthesia tubing was found snapped in bed.

• 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: 19031379
• Report Number: 19031379
• Device Sequence Number: 7338812
• 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): 03/11/2024
• Report Date (Section F): 03/11/2024

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
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 04/03/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/03/2024
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 03/11/2024