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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION / BECTON DICKINSON AND COMPANY CAREFUSION COAXIAL TEMNO EVOLUTION BIOPSY NEEDLE

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CAREFUSION / BECTON DICKINSON AND COMPANY CAREFUSION COAXIAL TEMNO EVOLUTION BIOPSY NEEDLE Back to Search Results
Model Number CTT2015
Device Problems Defective Device (2588); Protective Measures Problem (3015)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Event Description
This is not related to a pt. This is to report a lot defect with trouble sliding parts of the pieces together and getting resistance.
 
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Brand NameCAREFUSION COAXIAL TEMNO EVOLUTION
Type of DeviceBIOPSY NEEDLE
Manufacturer (Section D)
CAREFUSION / BECTON DICKINSON AND COMPANY
MDR Report Key7885157
MDR Text Key120728285
Report NumberMW5079854
Device Sequence Number1
Product Code FCG
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 09/14/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/17/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberCTT2015
Device Lot Number0001230108
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/14/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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