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U.S. Department of Health and Human Services

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

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CAREFUSION, INC TRAY SPN SPT24G3.5 L/B-D/E ANESTHESIA CONDUCTION KIT Back to Search Results
Model Number 405637
Device Problem Patient-Device Incompatibility (2682)
Patient Problem Awareness during Anaesthesia (1707)
Event Date 06/14/2020
Event Type  Injury  
Manufacturer Narrative
A device evaluation and/or device history review is anticipated, but is not complete. Upon completion, a supplemental report will be filed. (b)(4). Suspect product name and strength: bupivacaine hcl (0. 75%) with dextrose (8. 25%), 2 ml (marcaine). Pma/510k number: enforcement discretion.
 
Event Description
It was reported that tray spn spt24g3. 5 l/b-d/e failed to work. The following information was provided by the initial reporter: "it was reported that the marcaine in the spinal tray is compromised. Event description per attached email states: there is concern that these lots have issues with the marcaine that is supplied in the trays. There have been a few reports. Pt scheduled for c/section this am was positioned for a spinal in or. Dr. Administered spinal anesthesia without difficulty, was confident in placement. Patient did not receive adequate anesthesia to proceed with c/section, case was converted to general anesthesia and proceeded without incident. Dr. Was concerned that this is the second such case in 36 hours. He had the same incident on a patient on 6/14 at 2100. Again, dr. Was confident the placement was appropriate, but patient did not receive adequate anesthesia for the procedure and required general anesthesia. Dr. Is concerned that the marcaine in the spinal trays is compromised. ".
 
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Brand NameTRAY SPN SPT24G3.5 L/B-D/E
Type of DeviceANESTHESIA CONDUCTION KIT
Manufacturer (Section D)
CAREFUSION, INC
400 east foster rd
mannford OK 74044
MDR Report Key10477828
MDR Text Key206105234
Report Number2243072-2020-01325
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)Y
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,Followup
Report Date 02/05/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/01/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date09/30/2021
Device Model Number405637
Device Catalogue Number405637
Device Lot Number0001348196
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/07/2020
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/05/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/05/2020
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: 09/01/2020 Patient Sequence Number: 1
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