MAUDE Adverse Event Report: BBRAUN MEDICAL INC. PERFIX EPIDURAL CATHETER

Lot Number 0061536432

Device Problem Hole In Material (1293)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/07/2017

Event Type  malfunction  

Event Description

Placing epidural for patient and noticed a hole in the epidural catheter upon priming it for placement.The catheter was discarded and a new one opened.Epidural was successfully placed with no further problems on the second attempt/stick.

• Brand Name: PERFIX EPIDURAL CATHETER
• Type of Device: PERFIX EPIDURAL CATHETER
• Manufacturer (Section D): BBRAUN MEDICAL INC.; bethlehem PA 18018
• MDR Report Key: 6800806
• MDR Text Key: 83034014
• Report Number: MW5071633
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 0061536432
• Was Device Available for Evaluation?: No
• 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 Age: 27 YR
• Patient Weight: 92