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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION, INC BD SPINAL ANESTHESIA TRAY; ANESTHESIA CONDUCTION KIT
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CAREFUSION, INC BD SPINAL ANESTHESIA TRAY; ANESTHESIA CONDUCTION KIT Back to Search Results
Model Number 405621
Device Problem Patient-Device Incompatibility (2682)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/10/2021
Event Type  malfunction  
Event Description
It was reported that the bd spinal anesthesia tray had anesthesia that did not work on 6 patients.The following information was provided by the initial reporter: it was reported by the distributor that the anesthetic solution did not work in six patients.
 
Manufacturer Narrative
Date of event: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
 
Manufacturer Narrative
H6: investigation summary no photos or samples were received by our quality team for evaluation therefore the failure mode could not be verified.A review of the internal manufacturing device records and raw material history files for the reported lot number 0001425486 was performed and no recorded quality problems or rejections related to this incident were found.Product undergoes inspections during manufacturing, no issues related to the reported incident were identified, all procedural and functional requirements for product release have been met.Based on the available information we are not able to identify a root cause at this time.H3 other text : see h10.
 
Event Description
It was reported that the bd spinal anesthesia tray had anesthesia that did not work on 6 patients.The following information was provided by the initial reporter: it was reported by the distributor that the anesthetic solution did not work in six patients.
 
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Brand Name
BD SPINAL ANESTHESIA TRAY
Type of Device
ANESTHESIA 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 Key13397926
MDR Text Key286264962
Report Number1625685-2022-00025
Device Sequence Number1
Product Code CAZ
UDI-Device Identifier00382904056216
UDI-Public00382904056216
Combination Product (y/n)N
PMA/PMN Number
DISCRETION
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Distributor
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 02/18/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/31/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date06/30/2022
Device Model Number405621
Device Catalogue Number405621
Device Lot Number0001425486
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 Manufactured07/20/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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