MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. PERIFIX CONTINUOUS EPIDURAL ANESTHESIA CATHETER; EPIDURAL CATHETER

Catalog Number 332081

Device Problem Positioning Problem (3009)

Patient Problem No Information (3190)

Event Date 04/25/2018

Event Type  malfunction  

Event Description

Epidural catheter is coming out of epidural clamp device, resulting in epidural catheter leaving the chamber of the clamp and exposed to air, leaking, infection, etc.

• Brand Name: PERIFIX CONTINUOUS EPIDURAL ANESTHESIA CATHETER
• Type of Device: EPIDURAL CATHETER
• Manufacturer (Section D): B. BRAUN MEDICAL INC. ; 901 marcon blvd. ; allentown PA 18110 9512
• MDR Report Key: 7564939
• MDR Text Key: 110085100
• Report Number: MW5077595
• 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: 05/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2019
• Device Catalogue Number: 332081
• Device Lot Number: 0061610395
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2018
• 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: 22 YR
• Patient Weight: 33