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

Catalog Number	A4209-22
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/20/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the local anesthesia contained in a portex® spinal kit was not working.No injury was reported.

• Brand Name: PORTEX® SPINAL KIT
• Common Device Name: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 7041178
• Report Number: 3012307300-2017-02447
• Device Sequence Number: 2037119
• Product Code: CAZ
• UDI-Device Identifier: 20351688082548
• UDI-Public: 20351688082548
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/17/2017

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: No Information
• Device Expiration Date: 11/01/2018
• Device Catalogue Number: A4209-22
• Device Lot Number: 3439820
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/26/2017
• Initial Report FDA Received Date: 11/17/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1