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

Catalog Number	NEPI-NLD-15545C-21
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Awareness during Anaesthesia (1707)
Date of Event	07/01/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that at an anesthesia department meeting it was discovered that a portex® spinal anesthesia tray had not worked at all.

• 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: 7759162
• Report Number: 3012307300-2018-03176
• Device Sequence Number: 13773005
• Product Code: CAZ
• UDI-Device Identifier: 15019517115611
• UDI-Public: 15019517115611
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/01/2020
• Device Catalogue Number: NEPI-NLD-15545C-21
• Device Lot Number: 3630580
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/13/2018
• Initial Report FDA Received Date: 08/07/2018
• 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: Required Intervention