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

Model Number	552155 CESK
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/07/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Epidural catheter became disconnected at alligator clip.

• 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: 19759954
• Report Number: 19759954
• Device Sequence Number: 8850700
• 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): 06/18/2024
• Report Date (Section F): 06/18/2024

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 CESK
• Device Catalogue Number: 552155
• Device Lot Number: 0061929966
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 07/17/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/17/2024
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 25 DA
• Patient Sex: Female
• Patient Weight: 4 KG
• Patient Race: Black Or African American
• Date Report Sent to FDA: 06/18/2024