MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX® SPINAL ANESTHESIA TRAYS; PORTEX® SPINAL ANESTHESIA TRAYS, PRODUCT CODE CAZ

Catalog Number	NLD-15248C-22/25
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There are two potential lot numbers involved with this complaint and they are as follows: 3177846 and 3120762.
Event or Problem Description
It was reported that the hospital had multiple incidents of drug failures with bupvivaine 0.75% in dectrose 8.25%, @ ml procedure drug vial that is in the spinal tray.No adverse health outcomes were reported.

• Brand Name: PORTEX® SPINAL ANESTHESIA TRAYS
• Common Device Name: PORTEX® SPINAL ANESTHESIA TRAYS, PRODUCT CODE CAZ
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 7508290
• Report Number: 3012307300-2018-10169
• Device Sequence Number: 1254427
• Product Code: CAZ
• UDI-Device Identifier: 20351688078572
• UDI-Public: 20351688078572
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/11/2018

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: NLD-15248C-22/25
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/28/2016
• Initial Report FDA Received Date: 05/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1