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

Device Problem Defective Device (2588)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

There are two potential lot numbers involved with this complaint and they are as follows: 3177846 and 3120762.

Event 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
• Type of Device: PORTEX® SPINAL ANESTHESIA TRAYS, PRODUCT CODE CAZ
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): SMITHS MEDICAL NORTH AMERICA; 10 bowman drive; keene NH 03431 0724
• Manufacturer Contact: halverson ; 6000 nathan lane north; minneapolis, MN 55442 ; 7633833310
• MDR Report Key: 7508290
• MDR Text Key: 108156168
• Report Number: 3012307300-2018-10169
• Device Sequence Number: 1
• Product Code: CAZ
• UDI-Device Identifier: 20351688078572
• UDI-Public: 20351688078572
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: NLD-15248C-22/25
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/28/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1