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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
Catalog Number 400866
Device Problem Patient-Device Incompatibility (2682)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/03/2022
Event Type  malfunction  
Event Description
It was reported that 6 bd¿ spinal anesthesia trays had ineffective anesthesia.The following information was provided by the initial reporter: " past few weeks we have had 2 anesthesiologist have the same issues with patients feeling warmth , tingling , and can still lift leg".
 
Manufacturer Narrative
A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Date of event: unknown.The date received by manufacturer has been used as a default.
 
Event Description
It was reported that 6 bd¿ spinal anesthesia trays had ineffective anesthesia.The following information was provided by the initial reporter: " past few weeks we have had 2 anesthesiologist have the same issues with patients feeling warmth , tingling , and can still lift leg".
 
Manufacturer Narrative
H.6.Investigation: 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 0001437693 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.
 
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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 Key13538175
MDR Text Key296329153
Report Number1625685-2022-00032
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
NA
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 03/21/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/15/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date06/30/2022
Device Catalogue Number400866
Device Lot Number0001437693
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/21/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/19/2021
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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