MAUDE Adverse Event Report: B. BRAUN MEDICAL, INC. EPIDURAL PERIFIX FX ANESTHESIA TRAY; CATHETER, CONDUCTION, ANESTHETIC

Catalog Number	555110 CESK
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/09/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Epidural catheter unable to be removed, required surgical removal.Fda safety report id# (b)(4).

• Brand Name: EPIDURAL PERIFIX FX ANESTHESIA TRAY
• Common Device Name: CATHETER, CONDUCTION, ANESTHETIC
• Manufacturer (Section D): B. BRAUN MEDICAL, INC.; bethlehem PA 18018 3524
• MDR Report Key: 15242082
• Report Number: MW5111510
• Device Sequence Number: 6599671
• Product Code: BSO
• UDI-Device Identifier: 04046964313639
• UDI-Public: 04046964313639
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 08/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2023
• Device Catalogue Number: 555110 CESK
• Device Lot Number: 0061817143
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/16/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female