MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. PERIFIX CATHETER CONNECTOR; ANESTHESIA CONDUCTION KIT

Device Problems Detachment of Device or Device Component (2907); Positioning Problem (3009)

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

Event Date 08/28/2018

Event Type  malfunction  

Event Description

Pt had an epidural placed at about 0520 in the morning.At about 1000, as the nurse adjusted the pt's position in bed, she noticed the epidural catheter hanging down off the side of the bed, unconnected from the pump tubing.Upon further investigation, she found the connector closed, but was able to open it with minimal effort.While discussing this incident with other nurses on the unit, they reported 2 other similar incidents where the connector was found open and the tubing no longer attached appropriately.In the incident regarding the pt in this report, the epidural catheter was removed and a whole new epidural was placed.

• Brand Name: PERIFIX CATHETER CONNECTOR
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; allentown PA 18109
• MDR Report Key: 7864363
• MDR Text Key: 119944335
• Report Number: MW5079686
• 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: 09/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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 Outcome(s): Other
• Patient Age: 26 YR