MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. PERIFLEX FX CONTINUOUS EPIDURAL ANESTHESIA; ANESTHESIA CONDUCTION KIT

Device Problems Break (1069); Material Frayed (1262)

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

Event Date 05/13/2019

Event Type  malfunction  

Event Description

The epidural catheter tubing was found to be broken/frayed at the yellow round connector piece between the pt and the epidural pump.It had to be removed and replaced with a new epidural.Fda safety report id# (b)(4).

• Brand Name: PERIFLEX FX CONTINUOUS EPIDURAL ANESTHESIA
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): B. BRAUN MEDICAL INC.
• MDR Report Key: 8623817
• MDR Text Key: 145627263
• Report Number: MW5086732
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): Y
• 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: 05/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• 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 Age: 24 YR
• Patient Weight: 84