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U.S. Department of Health and Human Services

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

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CAREFUSION, INC BD¿ WHITACRE SPINAL ANESTHESIA TRAY ANESTHESIA CONDUCTION KIT Back to Search Results
Catalog Number 405672
Device Problem Therapeutic or Diagnostic Output Failure (3023)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/16/2019
Event Type  Injury  
Manufacturer Narrative
Medical device expiration date: unknown. Pma / 510(k)#: enforcement discretion. 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.
 
Event Description
It was reported that bd¿ whitacre spinal anesthesia tray was used with bupivacaine and it did not work. The patient's course of treatment had to be changed. The following information was provided by the initial reporter: material no. : 405672. Batch: unknown. It was reported that the bupivacaine did not work and the patients had to be converted to general anesthesia. For patient (b)(6) (4/5). A patient was to undergo spinal anesthesia as primary anesthesia, but was still able to move their leg. Staff had to convert to general anesthesia. Similar results with multiple cases on the same day.
 
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Brand NameBD¿ WHITACRE SPINAL ANESTHESIA TRAY
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 Key8596663
MDR Text Key144663424
Report Number1625685-2019-00029
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
SEE H.10
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 05/17/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/09/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number405672
Device Lot NumberUNKNOWN
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 Received04/23/2019
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: 05/09/2019 Patient Sequence Number: 1
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