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

Model Number PRODUCT # CE18TK

Device Problems Component Missing (2306); Failure to Infuse (2340)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/15/2019

Event Type  malfunction  

Event Description

The first kit opened for the epidural did not contain an epidural catheter. A replacement kit was obtained to start the epidural. After obtaining a second kit, the epidural catheter was inserted into the pt and fluid was pushed to be administered. However, the medication would not inject through the catheter. The catheter was pulled from the pt and the physician attempted to inject the medication through the catheter. Again the fluid did not go through the catheter. After these attempts, a different brand was used to place the epidural.

• Brand Name: PERIFIX CONTINUOUS EPIDURAL ANESTHESIA TRAY
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): B. BRAUN MEDICAL INC.
• MDR Report Key: 8496710
• MDR Text Key: 141454948
• Report Number: MW5085677
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 03/19/2019

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 04/08/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 04/30/2020
• Device Model Number: PRODUCT # CE18TK
• Device Lot Number: 0061639393
• Was Device Available for Evaluation?: No Answer Provided
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information

Was Device Evaluated by Manufacturer?

Is the Device Single Use?

• Is This a Reprocessed and Reused Single-Use Device?: No

Type of Device Usage