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

Catalog Number 555110 CESK

Device Problem Difficult to Remove (1528)

Patient Problem Insufficient Information (4580)

Event Date 08/09/2022

Event Type  Injury  

Event Description

Epidural catheter unable to be removed, required surgical removal.Fda safety report id# (b)(4).

• Brand Name: EPIDURAL PERIFIX FX ANESTHESIA TRAY
• Type of Device: CATHETER, CONDUCTION, ANESTHETIC
• Manufacturer (Section D): B. BRAUN MEDICAL, INC.; bethlehem PA 18018 3524
• MDR Report Key: 15242082
• MDR Text Key: 298152832
• Report Number: MW5111510
• Device Sequence Number: 1
• Product Code: BSO
• UDI-Device Identifier: 04046964313639
• UDI-Public: 04046964313639
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 08/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female