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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION, INC TRAY SPN QNKE22G3.5 L/B-D/E ANESTHESIA CONDUCTION KIT

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CAREFUSION, INC TRAY SPN QNKE22G3.5 L/B-D/E ANESTHESIA CONDUCTION KIT Back to Search Results
Catalog Number 405609
Device Problem Device Markings/Labelling Problem (2911)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/29/2019
Event Type  malfunction  
Manufacturer Narrative
Medical device expiration date: unknown. The customer's address is unknown. Unknown, (b)(6), 00000 usa has been used as a default. A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed. Device manufacture date: unknown.
 
Event Description
It was reported that the tray spn qnke22g3. 5 l/b-d/e label did not state that it contained bupivacaine, while another tray label did. The missing information was noticed before use. The following information was provided by the initial reporter: "health professional stated that she has two of the same 405609 tray (was not provided lot # but said it could be obtained) and one label stated it contains bupivacaine while the other did not say this. ".
 
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Brand NameTRAY SPN QNKE22G3.5 L/B-D/E
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 Key8897949
MDR Text Key203325454
Report Number1625685-2019-00093
Device Sequence Number1
Product Code CAZ
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 08/26/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/15/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number405609
Device Lot NumberUNKNOWN
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 Received07/31/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 08/15/2019 Patient Sequence Number: 1
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