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 04/14/2018

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: 7564911
• MDR Text Key: 110072105
• Report Number: MW5077591
• Device Sequence Number: 1
• Product Code: BSO
• 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

• 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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/01/2018
• 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: 25 YR
• Patient Weight: 100