MAUDE Adverse Event Report: ST PAUL PAIN MANAGEMENT PORTEX EPIDURAL CONTINUOUS TRAYS

Model Number 18 GUAGE

Device Problem Fluid/Blood Leak (1250)

Patient Problem Pain (1994)

Event Date 07/01/2020

Event Type  malfunction  

Event Description

Information received a smiths medical pain management|portex epidural continuous trays malfunctioned.The user noticed that the device leaked.Issue observed on the whole box.They had to use another device from another lot number.Due to the event the patients pain was not relieved.The leak was noted at the upper end of the catheter tip.No serious patient adverse events was reported.

• Brand Name: PAIN MANAGEMENT PORTEX EPIDURAL CONTINUOUS TRAYS
• Type of Device: EPIDURAL
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• MDR Report Key: 10404172
• MDR Text Key: 202800997
• Report Number: 3012307300-2020-08164
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial
• Report Date: 08/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 18 GUAGE
• Device Catalogue Number: 100/391/128CZ
• Device Lot Number: 3951235
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/15/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/17/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1