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

Model Number 400868

Device Problem Defective Device (2588)

Patient Problem Insufficient Information (4580)

Event Date 07/14/2021

Event Type  malfunction  

Event Description

Failed spinal despite easy placement with csf (cerebrospinal fluid) swirl.Wanted to log lot# in case this happens again.

• Brand Name: BD 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: 12202122
• MDR Text Key: 262663324
• Report Number: 12202122
• 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: 07/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 400868
• Device Lot Number: 0001398064
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/14/2021
• Event Location: Hospital
• Date Report to Manufacturer: 07/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 14965 DA