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

Model Number 332220

Device Problems Difficult to Flush (1251); Failure to Infuse (2340)

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

Event Date 06/18/2020

Event Type  malfunction  

Event Description

Anesthesia provider reported after insertion of epidural catheter fluid was unable to be administered through the catheter, received immediate resistance.Tried repositioning epidural catheter 3 times, and still met resistance.Removed the epidural catheter and tried flushing catheter resistance met.No fluid flushed through the epidural catheter.Patient had to have a second epidural inserted.The second epidural tray that was used had a different lot number than the one that failed.Fda safety report id #: (b)(4).

• Brand Name: PERIFIX CONTINUOUS EPIDURAL ANESTHESIA TRAY
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): B BRAUN MEDICAL INC
• MDR Report Key: 10179967
• MDR Text Key: 196202878
• Report Number: MW5095138
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Type of Report: Initial
• Report Date: 06/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2021
• Device Model Number: 332220
• Device Lot Number: 0061715006
• 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 Outcome(s): Other
• Patient Age: 25 YR
• Patient Weight: 84