MAUDE Adverse Event Report: CAREFUSION, INC TRAY SPN SPT24G3.5 L/B-D/E ANESTHESIA CONDUCTION KIT

Model Number 405637

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Awareness during Anaesthesia (1707)

Event Date 06/14/2020

Event Type  Injury  

Manufacturer Narrative

A device evaluation and/or device history review is anticipated, but is not complete. Upon completion, a supplemental report will be filed. (b)(4). Suspect product name and strength: bupivacaine hcl (0. 75%) with dextrose (8. 25%), 2 ml (marcaine). Pma/510k number: enforcement discretion.

Event Description

It was reported that tray spn spt24g3. 5 l/b-d/e failed to work. The following information was provided by the initial reporter: "it was reported that the marcaine in the spinal tray is compromised. Event description per attached email states: there is concern that these lots have issues with the marcaine that is supplied in the trays. There have been a few reports. Pt scheduled for c/section this am was positioned for a spinal in or. Dr. Administered spinal anesthesia without difficulty, was confident in placement. Patient did not receive adequate anesthesia to proceed with c/section, case was converted to general anesthesia and proceeded without incident. Dr. Was concerned that this is the second such case in 36 hours. He had the same incident on a patient on 6/14 at 2100. Again, dr. Was confident the placement was appropriate, but patient did not receive adequate anesthesia for the procedure and required general anesthesia. Dr. Is concerned that the marcaine in the spinal trays is compromised. ".

• Brand Name: TRAY SPN SPT24G3.5 L/B-D/E
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): CAREFUSION, INC; 400 east foster rd; mannford OK 74044
• MDR Report Key: 10477828
• MDR Text Key: 206105234
• Report Number: 2243072-2020-01325
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): Y
• PMA/PMN Number: SEE H.10.
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 02/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 09/30/2021
• Device Model Number: 405637
• Device Catalogue Number: 405637
• Device Lot Number: 0001348196
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2020

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 02/05/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/05/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 09/01/2020 Patient Sequence Number: 1