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

Model Number REF 552020

Device Problem Mechanics Altered (2984)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 02/19/2019

Event Type  malfunction  

Event Description

Patient started complaining of feeling contractions following an epidural placement previously.Patient also stated that it was wet under her arm.After assessing the epidural it was discovered that the ¿clip¿ used to connect to the epidural tubing was undone.Epidural medicine stopped, doctor of anesthesiology notified.Doctor came to replace epidural.This is a new issue in last 2-3 months but becoming more frequent.

• Brand Name: BRAUN PERIFIX FX EPIDURAL ANESTHESIA TRAY
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): B. BRAUN MEDICAL, INC
• MDR Report Key: 8381685
• MDR Text Key: 137559771
• Report Number: MW5084513
• 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: 02/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2020
• Device Model Number: REF 552020
• Device Catalogue Number: PRODUCT CODE: CESK
• Device Lot Number: 0061639183
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 26 YR