MAUDE Adverse Event Report: ST PAUL PORTEX EPIDURAL CATHETERS; ANESTHESIA CONDUCTION KIT

Device Problem Disconnection (1171)

Patient Problem Pain (1994)

Event Date 03/08/2021

Event Type  malfunction  

Event Description

It was reported that the patient experienced a lack of pain relief because the catheter had become disconnected from the yellow connector/filter.The patient was in labor when this issue occurred and experienced acute pain.No further patient complications were reported in relation to this event.

• Brand Name: PORTEX EPIDURAL CATHETERS
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• MDR Report Key: 11671432
• MDR Text Key: 245575054
• Report Number: 3012307300-2021-03171
• 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: foreign,other,user facility
• Type of Report: Initial
• Report Date: 04/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/18/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1