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

Catalog Number NEPI-49663C-25

Device Problem Output Problem (3005)

Patient Problems Pain (1994); No Known Impact Or Consequence To Patient (2692)

Event Type  Injury  

Event Description

Information was received regarding a smiths medical pain management kit that the bupivacaine is not working on their patient.

Event Description

Additional information received stating that as a result, general anesthesia was used instead of a local agent.

• Brand Name: PORTEX® SPINAL ANESTHESIA TRAYS
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 8202886
• MDR Text Key: 131614429
• Report Number: 3012307300-2018-09064
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 02/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: NEPI-49663C-25
• Device Lot Number: 3540741
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention