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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION, INC BD¿ WHITACRE SPINAL TRAY; ANESTHESIA CONDUCTION KIT
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CAREFUSION, INC BD¿ WHITACRE SPINAL 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 03/24/2021
Event Type  Injury  
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 the anesthesia in the bd¿ whitacre spinal tray was ineffective during the surgery and general anesthesia had to be used.This occurred with 2 different patients on the same day.The following information was provided by the initial reporter: "they were 2 different patients on the same day.Spinal didn't hold during surgery, patient had to be put to sleep.This occurred on 2 cases that had spinal turned into generals.".
 
Event Description
It was reported that the anesthesia in the bd¿ whitacre spinal tray was ineffective during the surgery and general anesthesia had to be used.This occurred with 2 different patients on the same day.The following information was provided by the initial reporter: "they were 2 different patients on the same day.Spinal didn't hold during surgery, patient had to be put to sleep.This occurred on 2 cases that had spinal turned into generals.".
 
Manufacturer Narrative
H6: investigation summary one sample of lot 0001386255 was provided to our quality team for investigation.Through visual inspection, for the applicable sample (lidocaine / marcaine ¿ pfizer) the fluid color and overall appearance did appear acceptable.All indicators suggest product 405671 lot # 0001386255 contained a drug with acceptable potency, therefore the reported failure could not be verified.A review of the internal manufacturing device records and raw material history files for the lot 0001328077 was performed and no recorded quality problems or rejections related to this incident were found.Product undergoes inspections throughout manufacturing, no issues related to the reported incident were identified, all procedural and functional requirements for product release have been met.Based on the complaint investigation, the failure mode could not be confirmed and as a result a probable root cause could not be identified.Since no probable root cause was identified for this failure mode, the investigation was not able to identify any actions for this complaint.H3 other text : see h10.
 
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Brand Name
BD¿ WHITACRE SPINAL 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
katie swenson
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key11719570
MDR Text Key247444697
Report Number1625685-2021-00030
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 11/08/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/23/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date12/31/2021
Device Model Number405671
Device Catalogue Number405671
Device Lot Number0001386255
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/19/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/08/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/05/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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