MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX® CONTINUOUS EPIDURAL TRAY; ANESTHESIA CONDUCTION KIT

Catalog Number	8024-20
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	07/27/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while performing a lumbar epidural steroid injection, a portion of the catheter of a portex® continuous epidural tray broke off of the end and remained in the patient.At the time of the event, steroid was unable to be infused, so the doctor "grasped the catheter and needle together and pulled them out".The doctor then noticed that the end of the catheter was uniform and upon further observation, noticed that 9cm of the catheter was missing from the end.The patient was going to see a neurological surgeon at a later date.No permanent injury was reported.

• Brand Name: PORTEX® CONTINUOUS EPIDURAL TRAY
• Common Device Name: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 6785296
• Report Number: 3012307300-2017-01760
• Device Sequence Number: 19185402
• Product Code: CAZ
• UDI-Device Identifier: 00351688056088
• UDI-Public: 00351688056088
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/10/2017

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
• Operator of Device: Health Professional
• Device Catalogue Number: 8024-20
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/25/2017
• Initial Report FDA Received Date: 08/10/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 59 YR