MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY SPINAL ANESTHESIA TRAY; ANESTHESIA CONDUCTION KIT

Model Number 400866

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Discomfort (2330)

Event Date 02/27/2020

Event Type  malfunction  

Event Description

0630: scheduled repeat cesarean section.Easy spinal, 1st attempt by crna.Free flowing cerebrospinal fluid (csf) drops and swirl in syringe - 1.6ml of kit 0.75% bupivacaine + 10mcg fentanyl + 200mcg duramorph injected.Foley insertion not tolerated, patient able to move legs and differentiate cold, touch, sharp.Lot # of spinal kit - 0001311129.Patient had to have general anesthesia due to failed spinal.Notes from the operative report: "the patient was taken to the operating room where spinal anesthesia was performed, seemingly without complication, but was noted to be not effective at this point.Anesthesia determined she would require general anesthesia." general anesthesia was initiated without complication.

• Brand Name: SPINAL ANESTHESIA TRAY
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 10000518
• MDR Text Key: 189012410
• Report Number: 10000518
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 04/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 400866
• Device Catalogue Number: 400866
• Device Lot Number: 0001311129
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/20/2020
• Event Location: Hospital
• Date Report to Manufacturer: 04/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 9490 DA
• Patient Weight: 75