MAUDE Adverse Event Report: BRAUN PERIFIX CONTINUOUS EPIDURAL ANESTHESIA TRAY; EPIDURAL CATHETER

Lot Number 0061573999

Device Problems Break (1069); Detachment Of Device Component (1104); Physical Resistance (2578)

Patient Problems Tingling (2171); Foreign Body In Patient (2687)

Event Date 10/30/2017

Event Type  No Answer Provided  

Event Description

Upon placing epidural catheter at l4/5 level, pt experienced paresthesia on left side.Anesthesiologist withdrew catheter to readjust and encountered very little resistance, however, as pt jumped slightly, the catheter sheared off.About 5 cm was retained in presumed epidural space.No c/o pain, paresthesia, etc.

• Brand Name: PERIFIX CONTINUOUS EPIDURAL ANESTHESIA TRAY
• Type of Device: EPIDURAL CATHETER
• Manufacturer (Section D): BRAUN; flowood MS 39232
• MDR Report Key: 6995793
• MDR Text Key: 90941738
• Report Number: MW5073084
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2018
• Device Lot Number: 0061573999
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• 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: 51 YR