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

Model Number CE18TKST

Device Problem Disconnection (1171)

Patient Problem Pain (1994)

Event Type  malfunction  

Event Description

Pt received an epidural during operating room procedure on (b)(6) 2018.Pt was sent to the floor and on (b)(6) 2018 at approx.1pm, provider was notified that the epidural had been disconnected.Due to risk of infection, epidural was discontinued.Pain was ongoing since post op.Multiple other epidural tubings noted to have come disconnected as well and department of anesthesia is investigating and observing at this time as to whether it was human error or product defect.

• Brand Name: PERIFIX CONTINUOUS EPIDURAL ANESTHESIA TRAY
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): B BRAUN MEDICAL, INC.
• MDR Report Key: 7705779
• MDR Text Key: 114712378
• Report Number: MW5078483
• 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
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2019
• Device Model Number: CE18TKST
• Device Lot Number: 0061614140
• 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