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

Catalog Number	NEPI-NLD-15583C-21
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	Pain (1994)
Date of Event	12/04/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Potential lot number: 3504495.
Event or Problem Description
It was reported that a portex® spinal anesthesia tray was not effective.The patient reported no relief.The patient was given intravenous centenol in order to alleviate pain.No permanent injury was reported.
Additional Manufacturer Narrative
No device was returned for evaluation.A review of the device history record, incoming record, and sterilization certificate found no discrepancies.Assay testing was performed on the drug lot by the supplier and found that the product was processed according to validated specifications.Based on the evidence, no fault was able to be confirmed.

• Brand Name: PORTEX® SPINAL ANESTHESIA TRAY
• Common Device Name: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 7117936
• Report Number: 3012307300-2017-02571
• Device Sequence Number: 11080808
• Product Code: CAZ
• UDI-Device Identifier: 15019517115680
• UDI-Public: 15019517115680
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/07/2018

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 Catalogue Number: NEPI-NLD-15583C-21
• 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: 12/04/2017
• Supplement Date Received by Manufacturer: 01/17/2018
• Initial Report FDA Received Date: 12/14/2017
• Supplement Report FDA Received Date: 02/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Weight: 76