MAUDE Adverse Event Report: CAREFUSION, INC TRAY SPN WHIT25G3.5 L/B-D/E BLUE DRAPE ANESTHESIA CONDUCTION KIT

Model Number 405672

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Awareness during Anaesthesia (1707); Insufficient Information (4580)

Event Date 11/04/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(6). Pma/510(k)#: enforcement discretion. A device evaluation and/or device history review is anticipated, but is not complete. Upon completion, a supplemental report will be filed. (b)(4).

Event Description

It was reported that tray spn whit25g3. 5 l/b-d/e blue drape anesthesia was ineffective. This occurred on 8 occasions. The following information was provided by the initial reporter: material no: 405672 batch no: 0001378841. It was reported that: some of the bupivicaine 0. 75% from the kits were ineffective. Event description per email states: one of the anesthesia nurses alerted me this morning of a problem with some of the spinal kits. She said that some of the bupivicaine 0. 75% is not working on patients and they are now pulling that out of the pyxis, so we are wasting the bupivicaine in the kits. She was unable to retrieve because the anesthesiologists have been throwing the kits into the sharps buckets. She knows of 6 or 8 kits with issues, {in a couple locations}.

• Brand Name: TRAY SPN WHIT25G3.5 L/B-D/E BLUE DRAPE
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): CAREFUSION, INC; 400 east foster rd; mannford OK 74044
• MDR Report Key: 10929859
• MDR Text Key: 230355459
• Report Number: 1625685-2020-00098
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• 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
• Report Date: 03/08/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 12/01/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 12/31/2021
• Device Model Number: 405672
• Device Catalogue Number: 405672
• Device Lot Number: 0001378841
• Was Device Available for Evaluation?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 03/08/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/19/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial