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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 405671
Device Problem Patient-Device Incompatibility (2682)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/20/2022
Event Type  malfunction  
Event Description
It was reported that 3 bd spinal anesthesia trays experienced anesthesia that would not work.The following information was provided by the initial reporter: we had 3 failed spinals with this lot number on the same day that were placed by experienced providers.The procedures were then performed on these patients a second time using a different lot number and worked as intended.The patients in these cases did not get numb (anesthetized) when using the bupivacaine in those listed kits.So essentially ineffective anesthesia.There was no adverse event other than we had to reposition those patients and place a second spinal anesthetic using kits from another lot.These were experienced providers, so highly unusual occurrence of 3 in one day.
 
Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
 
Event Description
It was reported that 3 bd spinal anesthesia trays experienced anesthesia that would not work.The following information was provided by the initial reporter: we had 3 failed spinals with this lot number on the same day that were placed by experienced providers.The procedures were then performed on these patients a second time using a different lot number and worked as intended.The patients in these cases did not get numb (anesthetized) when using the bupivacaine in those listed kits.So essentially ineffective anesthesia.There was no adverse event other than we had to reposition those patients and place a second spinal anesthetic using kits from another lot.These were experienced providers, so highly unusual occurrence of 3 in one day.
 
Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 27-jun-2022.23 sealed trays were provided to our quality team for investigation.Upon visual inspection of the retention sample ampules and fluids it was observed that retention samples were clear and colorless therefore, the reported failure mode was not confirmed.A review of the internal manufacturing device records and raw material history files for the reported lot number 0001465346 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.
 
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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 Key14957892
MDR Text Key304455711
Report Number1625685-2022-00074
Device Sequence Number1
Product Code CAZ
UDI-Device Identifier00382904056711
UDI-Public00382904056711
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 09/22/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/08/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number405671
Device Catalogue Number405671
Device Lot Number0001465346
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received09/22/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/02/2022
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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