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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION D.R. 203 LTD. COAXIAL ACHIEVE BIOPSY DEVICE BIOPSY NEEDLE

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CAREFUSION D.R. 203 LTD. COAXIAL ACHIEVE BIOPSY DEVICE BIOPSY NEEDLE Back to Search Results
Model Number 14G11CM
Device Problem Retraction Problem (1536)
Patient Problem No Information (3190)
Event Date 09/04/2018
Event Type  malfunction  
Event Description
Needle would not retract after first successful biopsy.
 
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Brand NameCOAXIAL ACHIEVE BIOPSY DEVICE
Type of DeviceBIOPSY NEEDLE
Manufacturer (Section D)
CAREFUSION D.R. 203 LTD.
MDR Report Key7859666
MDR Text Key119801439
Report NumberMW5079665
Device Sequence Number0
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
Type of Report Initial
Report Date 09/05/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/07/2018
Is this a Product Problem Report? Yes
Device Operator
Device Model Number14G11CM
Device Lot Number0001223506
Was Device Available for Evaluation? No
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?
Type of Device Usage

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