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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION, INC TRAY SPN WHIT25G3.5 L/B-D/E PLAST DRAPE ANESTHESIA CONDUCTION KIT

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CAREFUSION, INC TRAY SPN WHIT25G3.5 L/B-D/E PLAST DRAPE 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 08/18/2021
Event Type  malfunction  
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 tray spn whit25g3. 5 l/b-d/e plast drape had ineffective anesthesia. The following information was provided by the initial reporter: "today i was notified by anesthesia that the bupivacaine in spinal kit. Does not appear to be effective. ".
 
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Brand NameTRAY SPN WHIT25G3.5 L/B-D/E PLAST DRAPE
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
katie swenson
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key12474390
MDR Text Key271472200
Report Number1625685-2021-00062
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
D219092
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 02/18/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/15/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/31/2021
Device Model Number405671
Device Catalogue Number405671
Device Lot Number0001389399
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 Manufactured10/23/2020
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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