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

Catalog Number 405672

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Therapeutic Response, Decreased (2271)

Event Date 06/11/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that treatment failure occurred during use with trays spn whit25g3. 5 l/b-d/e blue drape. The following information was provided by the initial reporter: "it was reported that it took 20 minutes for the patient to become numb. Per customer email: good morning, we currently use lawson 659015 spinal tray. Surgery reported to us they are having problem with lot number 0001271310. They tried 4 of this lot number on a patient, it took over 20 minutes for the patient to become numb. They will not use this lot number anymore¿we currently have 17 of these spinal trays with this lot number. Any help you can give us on this issue would be greatly appreciated. ".

• 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
• Manufacturer (Section G): CAREFUSION, INC; 400 east foster rd; mannford OK 74044
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652341
• MDR Report Key: 8745037
• MDR Text Key: 149554564
• Report Number: 1625685-2019-00061
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: DISCRETION
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 02/28/2021
• Device Catalogue Number: 405672
• Device Lot Number: 0001271310
• Was Device Available for Evaluation?: No Answer Provided
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 06/11/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/07/2018
• 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: 06/28/2019 Patient Sequence Number: 1