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

Catalog Number 49661C-25

Device Problem Defective Device (2588)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/14/2017

Event Type  malfunction  

Event Description

It was reported that a bupivacaine medication in portex® spinal kits was ineffective.No patient injury reported.

• Brand Name: PORTEX® SPINAL KITS
• Type of Device: ANESTHESIA CONDUCTION KIT
• 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: dave halverson ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 7508227
• MDR Text Key: 108050990
• Report Number: 3012307300-2018-10257
• Device Sequence Number: 1
• Product Code: CAZ
• UDI-Device Identifier: 00351688047116
• UDI-Public: 00351688047116
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 49661C-25
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/21/2017
• Initial Date FDA Received: 05/11/2018
• Was Device Evaluated by Manufacturer?: No
• 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
• Treatment: BUPIVACAINE