MAUDE Adverse Event Report: CAREFUSION, INC BD¿ WHITACRE SPINAL TRAY ANESTHESIA CONDUCTION KIT

Model Number 405671

Device Problem Patient-Device Incompatibility (2682)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/22/2020

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown. The date received by manufacturer has been used for this field. Medical device expiration date: unknown. A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed. Device manufacture date: unknown. (b)(4).

Event Description

It was reported that the marcaine anesthesia in the bd¿ whitacre spinal tray was ineffective during use. The following information was provided by the initial reporter: "i was recently notified that the drugs in some of our bd spinal kits have not been as effective as hoped. Anecdotally, this same issue happened last summer. There is some concern that the heat could be affecting the items. Can you tell me how the below kit is being stored. " "i know of 4 times in a one week period. After that we started not using the marcaine in the kits. I don¿t know the exact week, but i am thinking the first full week in july. We had one adverse event from a patient with a spinal headache. She had to have 2 spinals as the first one was the bad marcaine".

• Brand Name: BD¿ WHITACRE SPINAL TRAY
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): CAREFUSION, INC; 400 east foster rd; mannford OK 74044
• MDR Report Key: 10405500
• MDR Text Key: 206822382
• Report Number: 1625685-2020-00073
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• PMA/PMN Number: DISCRETION
• 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: 12/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 405671
• Device Catalogue Number: 405671
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 12/23/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 08/13/2020 Patient Sequence Number: 1