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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION, INC TRAY SPN SPT24G3.5 B/L/E ANESTHESIA CONDUCTION KIT

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CAREFUSION, INC TRAY SPN SPT24G3.5 B/L/E ANESTHESIA CONDUCTION KIT Back to Search Results
Catalog Number 405707
Device Problem Component Missing (2306)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/10/2019
Event Type  malfunction  
Manufacturer Narrative
Device expiration date: unknown. 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 the tray spn spt24g3. 5 b/l/e caused a patient to be transferred to another hospital when "the tray was missing bupivacaine and marcaine. ".
 
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Brand NameTRAY SPN SPT24G3.5 B/L/E
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 Key8388227
MDR Text Key138109069
Report Number1625685-2019-00014
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 health professional,other,use
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 03/19/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/04/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number405707
Device Lot Number0001248934
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 Received02/13/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/10/2018
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: 03/04/2019 Patient Sequence Number: 1
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