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

Catalog Number	NEPI-15600-20
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/28/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received indicating that approximately 5cm of a smiths medical portex® epidural catheter was left in the patient.There were no reported adverse effects.

• Brand Name: PORTEX® EPIDURAL MINIPACKS
• Common Device Name: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): SMITHS MEDICAL ASD; INC.; 6000 nathan lane n; minneapolis, MN 55442
• MDR Report Key: 8129685
• Report Number: 3012307300-2018-08614
• Device Sequence Number: 19143426
• Product Code: CAZ
• UDI-Device Identifier: 15019517114720
• UDI-Public: 15019517114720
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: E332605
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/04/2018

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: No Information
• Device Expiration Date: 01/01/2020
• Device Catalogue Number: NEPI-15600-20
• Device Lot Number: 3655687
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/05/2018
• Initial Report FDA Received Date: 12/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1