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

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/01/2020

Event Type  malfunction  

Event Description

Information was received indicating that following the surgical procedure, a leak occurred to a smiths medical portex continuous epidural.It was reported that the hinge part of the epifuse connector had been found damaged.There were no reported adverse effects.

Manufacturer Narrative

Other, other text: device evaluation- the device was returned for evaluation.The examination of the returned device showed the epifuse connector component had damage at the hinge.The issue was determined consistent with a manufacturing issue with the connector.The connector supplier was notified in response to this issue.No corrective action has been identified at this time.

• Brand Name: PORTEX CONTINUOUS EPIDURAL TRAY
• Type of Device: ANESTHESIA CONDUCTION KIT
• MDR Report Key: 10618801
• MDR Text Key: 209538860
• Report Number: 3012307300-2020-10044
• 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,Followup
• Report Date: 11/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/02/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1