MAUDE Adverse Event Report: BRAUN / B. BRAUN MELSUNGEN AG PERIFLEX EPIDURAL ANESTHESIA TRAY; ANESTHESIA CONDUCTION KIT

Lot Number 0061747995

Device Problem Material Separation (1562)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/07/2021

Event Type  malfunction  

Event Description

Upon removal of periflex epidural catheter, a portion of catheter tip was retained.Retained portion left in place.Fda safety report id # (b)(4).

• Brand Name: PERIFLEX EPIDURAL ANESTHESIA TRAY
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): BRAUN / B. BRAUN MELSUNGEN AG
• MDR Report Key: 11169999
• MDR Text Key: 227081362
• Report Number: MW5098813
• Device Sequence Number: 1
• Product Code: CAZ
• UDI-Device Identifier: 0061732989
• UDI-Public: 0061732989
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Type of Report: Initial
• Report Date: 01/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 0061747995
• 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: 71 YR