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

Model Number 400866

Patient Problems Anxiety (2328); Inadequate Pain Relief (2388)

Event Date 11/30/2023

Event Type  malfunction  

Event Description

Patient schedule for elective post-partum tubal ligation under spinal anesthesia.Procedure described in pse as easy spinal with easy aspiration prior to and after injection of intrathecal anesthetic (bupivacaine 0.75% with dextrose 8.25%).Despite typical dose used (12 mg), trendellenderg position, and adequate time used to set up, spinal anesthesia was inadequate.Patient became very anxious and decision to proceed to geta was made.

• Brand Name: BD SPINAL ANESTHESIA TRAY
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): BECTON DICKINSON AND COMPANY
• MDR Report Key: 18282792
• MDR Text Key: 330046238
• Report Number: MW5148936
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 12/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 400866
• Device Lot Number: 0001517987
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 24 YR
• Patient Sex: Female
• Patient Weight: 75 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White