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

Model Number 405671

Device Problem Patient-Device Incompatibility (2682)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/13/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that during use with a bd tray spn whit25g3. 5 l/b-d/e plast drape the marcaine is ineffective on an unspecified number of patients. The following information was provided by the initial reporter: it was reported that the marcaine is ineffective on patients. Additionally, on 2020-7-22 the bd sales consultant provided the following additional information: 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. I had a customer complain that marcaine from lot #0001350501 is bad. They are currently pulling different marcaine for the defective lots. They state that it is not effective on patients.

• Brand Name: BD TRAY SPN WHIT25G3.5 L/B-D/E PLAST DRAPE
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): CAREFUSION, INC; 400 east foster rd; mannford OK 74044
• MDR Report Key: 10365720
• MDR Text Key: 206939660
• Report Number: 1625685-2020-00068
• 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: 10/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 09/30/2021
• Device Model Number: 405671
• Device Catalogue Number: 405671
• Device Lot Number: 0001350501
• Was Device Available for Evaluation?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 07/13/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/16/2020
• 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: 08/04/2020 Patient Sequence Number: 1