MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY BC CONTINUOUS EPIDURAL TRAY; EPIDURAL CATHETER

Model Number 406310

Device Problems Obstruction of Flow (2423); Device Dislodged or Dislocated (2923)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/04/2014

Event Type  malfunction  

Event Description

Epidural catheter inserted and functioning properly for test dose.When trying to inject a dose post-op catheter was occluded.Feeling that the catheter was dislodged the catheter was removed.Upon inspection of the catheter the connector was obstructed-product defect.(b)(4).

• Brand Name: BC CONTINUOUS EPIDURAL TRAY
• Type of Device: EPIDURAL CATHETER
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY; franklin lakes NJ 07417
• MDR Report Key: 3685307
• MDR Text Key: 4240476
• Report Number: MW5034956
• Device Sequence Number: 1
• Product Code: BSO
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 406310
• Device Catalogue Number: DGW111303
• Other Device ID Number: (01)0038290406308
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/12/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 61 YR