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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
Model Number 405672
Device Problem Patient-Device Incompatibility (2682)
Patient Problem Awareness during Anaesthesia (1707)
Event Date 08/11/2020
Event Type  Injury  
Manufacturer Narrative
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 2 tray spn whit 25g3. 5 l/b-d/e blue drape experienced ineffective anesthesia -treatment failed to work during use. The following information was provided by the initial reporter: material no. 405672 batch no. 0001283016. Two patients on (b)(6) 2020, received pre-procedure spinal anesthesia which was ineffective and another type of anesthesia had to utilized by the medical provider. Sequestered tray and spinal medication is in the managers office awaiting pick 11p from supply chain.
 
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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
MDR Report Key10617134
MDR Text Key209839193
Report Number1625685-2020-00091
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
PMA/PMN Number
DISCRETION
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Type of Report Initial,Followup
Report Date 10/15/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/01/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number405672
Device Catalogue Number405672
Device Lot Number0001283016
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/10/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/23/2019
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: 10/01/2020 Patient Sequence Number: 1
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