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U.S. Department of Health and Human Services

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

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CAREFUSION, INC TRAY SPN WHIT25G3.5 L/B-D/E BLUE DRAPE ANESTHESIA CONDUCTION KIT Back to Search Results
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. ".
 
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Brand NameTRAY SPN WHIT25G3.5 L/B-D/E BLUE DRAPE
Type of DeviceANESTHESIA 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 Key8745037
MDR Text Key149554564
Report Number1625685-2019-00061
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
DISCRETION
Number of Events Reported1
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 Received06/28/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/28/2021
Device Catalogue Number405672
Device Lot Number0001271310
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 Received06/11/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/07/2018
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
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