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	Therapeutic or Diagnostic Output Failure (3023)
Health Effect - Clinical Code	Pain (1994)
Date of Event	12/06/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient was not receiving pain relief with the use of a portex® spinal anesthesia tray.The patient required extra pain medications.There was no patient injury associated with this occurrence.
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: 7149758
• Report Number: 3012307300-2017-02629
• Device Sequence Number: 16184071
• Product Code: CAZ
• UDI-Device Identifier: 30351688062905
• UDI-Public: 30351688062905
• 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: Health Professional
• Device Expiration Date: 03/01/2019
• Device Catalogue Number: NEPI_NLD_15583C-21
• Device Lot Number: 3504495
• 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: 12/13/2017
• Supplement Date Received by Manufacturer: 01/17/2018
• Initial Report FDA Received Date: 12/27/2017
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 74 YR
• Patient Weight: 96