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U.S. Department of Health and Human Services

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

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CAREFUSION, INC BD¿ SPINAL ANESTHESIA TRAYS ANESTHESIA CONDUCTION KIT Back to Search Results
Model Number 405673
Device Problem Patient-Device Incompatibility (2682)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/30/2021
Event Type  malfunction  
Event Description
It was reported that while using bd¿ spinal anesthesia trays, the surgical block was ineffective during surgery. This event occurred 3 times. There was no report of patient impact. The following information was provided by the initial reporter: "the last three attempts failed with the kit, patient reported legs were heavy but surgical block was not adequate for surgery.
 
Manufacturer Narrative
Date of event: unknown. The date received by manufacturer has been used for this field. A device evaluation is anticipated but has not yet begun. Upon completion of the investigation, a supplemental report will be filed.
 
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Brand NameBD¿ SPINAL ANESTHESIA TRAYS
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
phillip emmert
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key13098846
MDR Text Key287260196
Report Number1625685-2021-00105
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K953467
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 02/18/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/28/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number405673
Device Catalogue Number405673
Device Lot Number0001424586
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/18/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/13/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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