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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION, INC BD¿ SPINAL TRAY

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CAREFUSION, INC BD¿ SPINAL TRAY Back to Search Results
Catalog Number 405733
Device Problems Component Missing (2306); Device Markings/Labelling Problem (2911)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/26/2018
Event Type  malfunction  
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¿ spinal tray was missing label information. No serious injury or medical intervention was reported.
 
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Brand NameBD¿ SPINAL TRAY
Type of DeviceSPINAL TRAY
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
8015652845
MDR Report Key7974545
MDR Text Key124333020
Report Number1625685-2018-00045
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 11/09/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/17/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date01/31/2021
Device Catalogue Number405733
Device Lot Number0001253521
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/26/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/02/2018
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: 10/17/2018 Patient Sequence Number: 1
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