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

Model Number 332079

Device Problems No Flow (2991); Application Program Problem: Medication Error (3198)

Patient Problem No Information (3190)

Event Date 02/25/2015

Event Type  malfunction  

Event Description

Problem reported by crna (nurse anesthetist) with 2 epidural catheters back-to-back: "after properly sitting the catheters in the epidural space, i was unable to give medication through the clamp style catheter connector, despite trouble shooting it (including detaching and re-attaching, using a different connector from the same type of epidural tray).This has never happened to me before or since and i thought it should be reported to the manufacturer.

• Brand Name: PERIFIX FX CONTINUOUS EPIDURAL ANESTHESIA TRAY
• Type of Device: EPIDURAL CATHETER
• Manufacturer (Section D): B. BRAUN; bethlehem PA 18018
• MDR Report Key: 4603822
• MDR Text Key: 5700574
• Report Number: MW5041389
• Device Sequence Number: 1
• Product Code: CAZ
• 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: 03/05/2015
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 332079
• Device Catalogue Number: CE17TKFC
• Device Lot Number: 61410707
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1