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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 Problems Awareness during Anaesthesia (1707); Insufficient Information (4580)
Event Date 11/04/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(6). Pma/510(k)#: enforcement discretion. A device evaluation and/or device history review is anticipated, but is not complete. Upon completion, a supplemental report will be filed. (b)(4).
 
Event Description
It was reported that tray spn whit25g3. 5 l/b-d/e blue drape anesthesia was ineffective. This occurred on 8 occasions. The following information was provided by the initial reporter: material no: 405672 batch no: 0001378841. It was reported that: some of the bupivicaine 0. 75% from the kits were ineffective. Event description per email states: one of the anesthesia nurses alerted me this morning of a problem with some of the spinal kits. She said that some of the bupivicaine 0. 75% is not working on patients and they are now pulling that out of the pyxis, so we are wasting the bupivicaine in the kits. She was unable to retrieve because the anesthesiologists have been throwing the kits into the sharps buckets. She knows of 6 or 8 kits with issues, {in a couple locations}.
 
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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 Key10929859
MDR Text Key230355459
Report Number1625685-2020-00098
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
PMA/PMN Number
SEE H.10
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Type of Report Initial,Followup
Report Date 03/08/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/01/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/31/2021
Device Model Number405672
Device Catalogue Number405672
Device Lot Number0001378841
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/08/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/19/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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