MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX® EPIFUSE® EPIDURAL CATHETER CONNECTOR; ANESTHESIA CONDUCTION KIT

Catalog Number EPX1308/118JP

Device Problems Fluid/Blood Leak (1250); Material Integrity Problem (2978)

Patient Problems Low Blood Pressure/ Hypotension (1914); No Consequences Or Impact To Patient (2199)

Event Date 05/02/2018

Event Type  Injury  

Event Description

Information was received indicating that after two days of use this epidural catheter connector exhibited leakage.It was noted that there was damage to the hinge part of the connector.No adverse patient effects were reported.

Manufacturer Narrative

One epifuse connector was returned.The customer's reported problem was "two days after start of use, leakage occurred from the connector part.The customer confirmed damage of the hinge part on the epifuse connector".As a result of observing the sample, it was confirmed that the hinge part was broken into two parts.Cracks cannot be detected in the epifuse connector without bending the hinge part.The manufacturing and quality inspection processes were reviewed and considered adequate and correct.The root cause and timing of occurrence was not identified.

Manufacturer Narrative

Medical intervention included ett, mechanical ventilation with peep of 20, and vasopressor bp support.

• Brand Name: PORTEX® EPIFUSE® EPIDURAL CATHETER CONNECTOR
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 7550339
• MDR Text Key: 109496495
• Report Number: 3012307300-2018-01992
• 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,Followup
• Report Date: 11/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: EPX1308/118JP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/11/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/18/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 48 YR
• Patient Weight: 109