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

Catalog Number	NEPI-NLD-15597C-20
Medical Device Problem Code	Failure to Deliver (2338)
Health Effect - Clinical Codes	Weakness (2145); Numbness (2415)
Date of Event	04/01/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received indicating that following use of a smiths medical portex® spinal anesthesia tray the patient had diminished sensation and motor weakness; still feeling and moving legs.Subsequently, the patient was required to go under general anesthesia for the surgical procedure.There was no reported adverse effects.

• Brand Name: PORTEX® SPINAL ANESTHESIA TRAYS
• Common Device Name: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 7514100
• Report Number: 3012307300-2018-01595
• Device Sequence Number: 16570016
• Product Code: CAZ
• UDI-Device Identifier: 15019517115710
• UDI-Public: 15019517115710
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: E332605
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/14/2018

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: Physician
• Device Expiration Date: 10/01/2019
• Device Catalogue Number: NEPI-NLD-15597C-20
• Device Lot Number: 3566332
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/16/2018
• Initial Report FDA Received Date: 05/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1