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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION, INC BD¿ WHITACRE SPINAL TRAY ANESTHESIA CONDUCTION KIT

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CAREFUSION, INC BD¿ WHITACRE SPINAL TRAY ANESTHESIA CONDUCTION KIT Back to Search Results
Model Number 405671
Device Problem Patient-Device Incompatibility (2682)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/22/2020
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown. The date received by manufacturer has been used for this field. Medical 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. Device manufacture date: unknown. (b)(4).
 
Event Description
It was reported that the marcaine anesthesia in the bd¿ whitacre spinal tray was ineffective during use. The following information was provided by the initial reporter: "i was recently notified that the drugs in some of our bd spinal kits have not been as effective as hoped. Anecdotally, this same issue happened last summer. There is some concern that the heat could be affecting the items. Can you tell me how the below kit is being stored. " "i know of 4 times in a one week period. After that we started not using the marcaine in the kits. I don¿t know the exact week, but i am thinking the first full week in july. We had one adverse event from a patient with a spinal headache. She had to have 2 spinals as the first one was the bad marcaine".
 
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Brand NameBD¿ WHITACRE SPINAL TRAY
Type of DeviceANESTHESIA CONDUCTION KIT
Manufacturer (Section D)
CAREFUSION, INC
400 east foster rd
mannford OK 74044
MDR Report Key10405500
MDR Text Key206822382
Report Number1625685-2020-00073
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 12/28/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/13/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number405671
Device Catalogue Number405671
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/23/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 08/13/2020 Patient Sequence Number: 1
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