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

Device Problems Leak/Splash (1354); Fitting Problem (2183)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/01/2020

Event Type  malfunction  

Event Description

Information was received indicating that a medical fluid leak occurred to a smiths medical portex continuous epidural.It was reported that following connecting the epifuse connector to the flat filter, the edge of the silicone ring got caught up in between them; leading to leakage.It was suspected that the size of the silicone ring was larger than usual.There were no reported adverse patient effects.

• Brand Name: PORTEX CONTINUOUS EPIDURAL TRAY
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• MDR Report Key: 10162357
• MDR Text Key: 195392061
• Report Number: 3012307300-2020-06005
• 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: company representative,foreig
• Type of Report: Initial
• Report Date: 06/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/22/2020
• 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: Initial
• Patient Sequence Number: 1