MAUDE Adverse Event Report: SMITHS MEDICAL PORTEX CONTINUOUS EPIDURAL ADULT & PEDIATRIC

Model Number PORTEX CONTINUOUS EPIDURAL

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Abdominal Pain (1685)

Event Date 12/24/2013

Event Type  Injury  

Event Description

(b)(6) female with history of hereditary pancreatitis, chronic pancreatitis, and subsequent chronic epigastric pain was consulted for management of chronic abdominal pain.Tunnelled epidural catheter was placed for pain relief with great result prior to pt seeking second opinion for surgical intervention.The epidural catheter was dislodged from the epipump catheter connector requiring unexpected removal of the epidural catheter that had been working well for her pain control.The incidence of epidural catheter dislodgement from epifuse catheter connector occurred in both adult and pediatric pts, regardless of the type of epidural tray used (adult or pediatric).The dislodgement requires prompt removal of the epidural catheter to prevent potential infection.Dates of use: 1 month.Diagnosis or reason for use: portex continuous epidural kit is the one available for use.

• Brand Name: PORTEX CONTINUOUS EPIDURAL ADULT & PEDIATRIC
• Type of Device: PORTEX
• Manufacturer (Section D): SMITHS MEDICAL; dublin OH 43017
• MDR Report Key: 3599390
• MDR Text Key: 15930767
• Report Number: MW5034033
• Device Sequence Number: 1
• Product Code: CAZ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2015
• Device Model Number: PORTEX CONTINUOUS EPIDURAL
• Device Lot Number: 2542628
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 12 YR
• Patient Weight: 41