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

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 08/21/2020

Event Type  malfunction  

Event Description

Perifix epidural catheter inserted and when removed, there was approximately 1cm of catheter tip retained.Retained portion left in place.Fda safety report id# (b)(4).

• Brand Name: PERIFIX EPIDURAL ANESTHESIA TRAY CATHETER
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): B. BRAUN MEDICAL, INC.
• MDR Report Key: 10528047
• MDR Text Key: 206995445
• Report Number: MW5096587
• Device Sequence Number: 1
• Product Code: CAZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Type of Report: Initial
• Report Date: 09/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 72 YR