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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION, INC BD¿ TRAY SPN WHIT25G3.5 B-D/L X3802 ANESTHESIA CONDUCTION KIT

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CAREFUSION, INC BD¿ TRAY SPN WHIT25G3.5 B-D/L X3802 ANESTHESIA CONDUCTION KIT Back to Search Results
Catalog Number 405741
Device Problems Defective Component (2292); Therapeutic or Diagnostic Output Failure (3023)
Patient Problem Therapeutic Effects, Unexpected (2099)
Event Date 03/11/2019
Event Type  Injury  
Manufacturer Narrative
Pma/510(k)#: enforcement discretion. A device evaluation and/or device history review is anticipated, but is not complete. Upon completion, a supplemental report will be filed.
 
Event Description
It was reported that bd¿ tray spn whit25g3. 5 b-d/l x3802 was ineffective and did not numb the patient. This occurred on 3 separate occasions. The following information was provided by the initial reporter: ¿material no. : 405741. Batch/lot: 0001283015. It was reported that the "bupivacaine in tray was infective and did not numb the patient. Drug did not work properly. ". Customer text: "bupivacaine in tray was ineffective and did not numb the patient. Drug did not work properly. ".
 
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Brand NameBD¿ TRAY SPN WHIT25G3.5 B-D/L X3802
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
brett wilko
9450 south state street
sandy, UT 84070
8015652341
MDR Report Key8464536
MDR Text Key140356403
Report Number1625685-2019-00019
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
SEE H.10
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 04/24/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/29/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date05/31/2021
Device Catalogue Number405741
Device Lot Number0001283015
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/12/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/23/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 03/29/2019 Patient Sequence Number: 1
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