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 relief with th 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
The portex® spinal anesthesia tray was not returned.Review of the device history records, incoming records, and sterilization records found no discrepancies or anomalies.Assay testing performed by the supplier prior to release of the anesthetics were within specification for the drug lot numbers.The anesthetics are supplied items and the complaint notification was forwarded to the supplier.Based on available information and evidences, no product quality problem could be confirmed.The root cause is unconfirmed as no fault could be found.

• 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: 7135840
• Report Number: 3012307300-2017-02628
• Device Sequence Number: 85798
• 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): 01/30/2018

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 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: 12/13/2017
• Supplement Date Received by Manufacturer: 01/17/2018
• Initial Report FDA Received Date: 12/20/2017
• Supplement Report FDA Received Date: 01/30/2018
• 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: 37 YR
• Patient Weight: 61