MAUDE Adverse Event Report: B. BRAUN MELSUNGEN AG PERIFIX; ANESTHESIA CONDUCTION KIT

Device Problem Component Missing (2306)

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

Event Date 02/28/2019

Event Type  malfunction  

Event Description

Patient received an epidural for pain relief for a vaginal delivery.When it was time to take the epidural catheter out, at 1015, the tip was noted to be intact, but the blue paint to mark the tip was noted to be chipping off.The patient was informed and aware.

• Brand Name: PERIFIX
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): B. BRAUN MELSUNGEN AG; 901 marcon blvd.; allentown PA 18109
• MDR Report Key: 8394004
• MDR Text Key: 137976362
• Report Number: 8394004
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/04/2019
• Date Report to Manufacturer: 03/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1