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

Model Number	A3911-25
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/18/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received that the medication within a smiths medical portex spinal tray was injected into the patient by the anesthesiologist.However, the pain medication did not work and general anesthesia had to be used.No adverse patient effects were reported.

• Brand Name: PORTEX SPINAL TRAY
• Common Device Name: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 8438242
• Report Number: 3012307300-2019-01397
• Device Sequence Number: 11209041
• Product Code: CAZ
• UDI-Device Identifier: 30351688078159
• UDI-Public: 30351688078159
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/20/2019

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: 06/01/2020
• Device Model Number: A3911-25
• Device Catalogue Number: A3911-25
• Device Lot Number: 3722925
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2019
• Initial Report FDA Received Date: 03/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1