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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION, INC BD SPINAL ANESTHESIA TRAY 25 GAUGE 3.5 INCH ANESTHESIA CONDUCTION KIT

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CAREFUSION, INC BD SPINAL ANESTHESIA TRAY 25 GAUGE 3.5 INCH 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 03/21/2022
Event Type  malfunction  
Event Description
It was reported while using bd spinal anesthesia tray 25 gauge 3. 5 inch the anesthesia was ineffective. This occurred 5 times. There was no report of patient impact. The following information was provided by the initial reporter: it was reported by the consumer 5 failed spinals from bd spinal tray.
 
Manufacturer Narrative
Date of event is unknown; awareness date 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 TRAY 25 GAUGE 3.5 INCH
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 Key14110215
MDR Text Key289289061
Report Number1625685-2022-00046
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
DISCRETION
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 04/21/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/14/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/30/2022
Device Model Number405673
Device Catalogue Number405673
Device Lot Number0001443589
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/21/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/02/2021
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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