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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION 2200, INC. TEMNO EVOLUTION COAXIAL W/18 G X 15 CM NDL BIOPSY NEEDLE

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CAREFUSION 2200, INC. TEMNO EVOLUTION COAXIAL W/18 G X 15 CM NDL BIOPSY NEEDLE Back to Search Results
Model Number CTT1815
Device Problem Device Markings/Labelling Problem (2911)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/03/2017
Event Type  malfunction  
Event Description
A woman was undergoing a liver biopsy in interventional radiology. The introducer was the correct size but the biopsy gun was 10 cm even though it was taken out of a 15 cm package. There are no size identifiers on the device itself. The lines on the needles can be counted - 1 line
=
1 cm. Given that gun didn't reach the area to be biopsied, the physician switched to another biopsy gun. There was no harm to the patient. Manufacturer response for biopsy gun, temno evolution coaxial w/18 g x 15 cm ndl (per site reporter). On june 13th the radiology manager asked for follow-up. The company responded that the concern had been forwarded to the manufacturing site where it is being evaluated. According to the company's quality specialist the process can take up to 90 days.
 
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Brand NameTEMNO EVOLUTION COAXIAL W/18 G X 15 CM NDL
Type of DeviceBIOPSY NEEDLE
Manufacturer (Section D)
CAREFUSION 2200, INC.
400 east foster rd.
mannford OK 74044
MDR Report Key6696447
MDR Text Key79369759
Report Number6696447
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 User Facility
Reporter Occupation
Type of Report Initial
Report Date 07/06/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/10/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberCTT1815
Device Catalogue NumberCTT1815
Device Lot Number0000998280
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/16/2017
Is the Reporter a Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/06/2017
Event Location Hospital
Date Report to Manufacturer07/06/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 07/10/2017 Patient Sequence Number: 1
Treatment
NO
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