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

Model Number 333521

Device Problems Disconnection (1171); Device Slipped (1584); Contamination /Decontamination Problem (2895)

Patient Problem Insufficient Information (4580)

Event Date 09/22/2020

Event Type  malfunction  

Event Description

Epidural catheter line disconnected from hub.Slipped out of connector.Brief interruption of infusion.Contamination of catheter end.

• Brand Name: PERIFIX SOFTTIP EPIDURAL ANESTHESIA CATHETER
• Type of Device: EPIDURAL ANESTHESIA KIT
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 824 12th ave; bethlehem PA 18018
• MDR Report Key: 10710623
• MDR Text Key: 212311673
• Report Number: 10710623
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 10/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 333521
• Device Catalogue Number: 333521
• Device Lot Number: 0061643473
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/01/2020
• Event Location: Hospital
• Date Report to Manufacturer: 10/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1