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

Catalog Number 400866

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

Patient Problems Awareness during Anaesthesia (1707); Inadequate Pain Relief (2388)

Event Date 07/24/2020

Event Type  malfunction  

Event Description

A patient about to undergo total knee revision, was administered spinal anesthesia prior to the case.However, the spinal failed, and the patient went on to have general regional anesthesia.Notes from the procedural report: 08:42 - spinal performed by certified registered nurse anesthetist (crna).08:42 - sterile prep with chloraprep and draped.08:45 - vertebral interspace l3/4 located by palpation.08:45 - skin anesthetized with lidocaine 1%.08:45 - 25 g whitacre needle advanced to subarachnoid space using midline approach with introducer.Positive cerebrospinal fluid (csf).08:45 - spinal bupivacaine 0.75% 1.5 ml spinal.08:45 - number of attempts: 1.08:45 - patient did not report paresthesias.08:46 - patient positioned supine.08:49 - propofol bolus 50 mg iv.08:49 - temperature monitoring utilized: skin.08:49 - lidocaine 2% 60 mg iv.08:50 - cefazolin 2 g iv.08:52 - propofol infusion 60 mcg/kg/min (1000 mg per 100 ml) started.08:56 - informed medical doctor of anesthesiology (mda) that patient was still able to move her leg and could feel some pain if her right knee was bent.08:58 - patient safety: patient position supine; arms bilateral less than 90deg abducted; pressure points padded; eyes taped closed; 08:58 - anesthesia type: general, regional.08:58 - convective warmer placed on upper body set at 43 with high fan speed.08:58 - propofol infusion 90 mcg/kg/min (1000 mg per 100 ml) dose change.08:59 - induction presence.08:59 - per mda.Convert to general ¿ laryngeal mask airway (lma).As patient was able to wiggle her toes on right foot.The operative note indicates: "the patient was taken to the operating theater where spinal was performed.She still had some pain and therefore general anesthesia was induced." the procedure was carried out with no complications.

• Brand Name: SPINAL ANESTHESIA TRAY
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): BECTON DICKINSON AND COMPANY; one becton drive; franklin lakes NJ 07417
• MDR Report Key: 10465062
• MDR Text Key: 204733146
• Report Number: 10465062
• 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: 08/24/2020,08/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 400866
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/24/2020
• Event Location: Hospital
• Date Report to Manufacturer: 08/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 18250 DA
• Patient Weight: 70