MAUDE Adverse Event Report: B BRAUN PERIFIX; EPIDURAL ANESTHESIA KIT

Model Number	332209
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/13/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Epidural catheter sheared off at approximately 5.5cm, with distal portion retained in patient.

• Brand Name: PERIFIX
• Common Device Name: EPIDURAL ANESTHESIA KIT
• Manufacturer (Section D): B BRAUN; 824 twelfth avenue; bethlehem PA 18018
• MDR Report Key: 16060478
• Report Number: 16060478
• Device Sequence Number: 11271099
• Product Code: OGE
• UDI-Device Identifier: 04046964178160
• UDI-Public: 04046964178160
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 12/20/2022
• Report Date (Section F): 12/20/2022

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: Other
• Device Model Number: 332209
• Device Catalogue Number: 332209
• Device Lot Number: 0061843892
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 12/28/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/28/2022
• 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 Sex: Female
• Date Report Sent to FDA: 12/20/2022