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

Catalog Number	NEPI-NLD-15548-20
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received indicating that the drug supplied in this spinal tray showed no anesthetic effect.It was noted that the spinal anesthetic was properly administered by an experienced anesthesiologist with free flow of cerebrospinal fluid pre and post injection of the hyperbaric bupivacaine included in the kit.No adverse patient effects were reported.

• 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: 7642637
• Report Number: 3012307300-2018-02515
• Device Sequence Number: 14062375
• Product Code: CAZ
• UDI-Device Identifier: 35019517115653
• UDI-Public: 35019517115653
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 06/27/2018

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-15548-20
• Device Lot Number: 3564743
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/29/2018
• Initial Report FDA Received Date: 06/27/2018
• Patient Sequence Number: 1