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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION, INC TRAY SPN WHIT27G3.5 L/B-D/E ANESTHESIA CONDUCTION KIT
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CAREFUSION, INC TRAY SPN WHIT27G3.5 L/B-D/E ANESTHESIA CONDUCTION KIT Back to Search Results
Catalog Number 405699
Device Problem Patient-Device Incompatibility (2682)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/17/2020
Event Type  malfunction  
Manufacturer Narrative
There were multiple lot numbers reported to be involved. The information for each lot number is as follows: medical device lot #: 0001316092, medical device expiration date: 2021-05-31, device manufacture date: 2019-08-15. Medical device lot #: 0001318294, medical device expiration date: 2021-05-31, device manufacture date: 2019-09-03. 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 failed spinal blocks occurred with a tray spn whit27g3. 5 l/b-d/e. The following information was provided by the initial reporter, "anesthesia department experienced 3 failed or partial spinal blocks in a 16 hour period with the bupivacaine in the tray. Crna's will continue using our tray but will pull anesthetic from pharmacy. ".
 
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Brand NameTRAY SPN WHIT27G3.5 L/B-D/E
Type of DeviceANESTHESIA CONDUCTION KIT
Manufacturer (Section D)
CAREFUSION, INC
400 east foster rd
mannford OK 74044
MDR Report Key9930502
MDR Text Key202233213
Report Number1625685-2020-00038
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 08/20/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/06/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date05/31/2021
Device Catalogue Number405699
Device Lot NumberSEE. H.10
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/24/2020
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/17/2020
Was Device Evaluated by Manufacturer? Yes
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: 04/06/2020 Patient Sequence Number: 1
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