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Adverse Event Report

BARD PERIPHERAL VASCULAR TRUGUIDE COAXIAL BIOPSY NEEDLE   back to search results
Catalog Number C2016A
Event Date 11/10/2003
Event Type  Injury   Patient Outcome  Required Intervention;
Event Description

Patient undergoing ct guided liver biopsy with bard coaxial needle 19g. A single aspirate was performed with 20g needle successfully and without incident. Further attempts at placing additional needles were unsuccessful as if lumen was bent or collapsed. The physician tried to remove the 19g needle which broke in the middle. The lumen was partially collapsed. Portion of the needle remained in the liver and the outer portion was just outside the costocartilage. A portion of the remaining piece was surgically removed.

 
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Brand NameTRUGUIDE COAXIAL BIOPSY NEEDLE
Type of DeviceCOAXIAL BIOPSY NEEDLE
Baseline Brand NameTRUGUIDE COAXIAL BIOPSY NEEDLE
Baseline Generic NameCOAXIAL BIOPSY NEEDLE
Baseline Catalogue NumberC2016A
Baseline Device 510(K) Number
Baseline Device PMA Number
Manufacturer (Section F)
BARD PERIPHERAL VASCULAR
1625 west 3rd st.
po box 1740
tempe AZ 85281
Manufacturer (Section D)
BARD PERIPHERAL VASCULAR
1625 west 3rd st.
po box 1740
tempe AZ 85281
Manufacturer (Section G)
BARD REYNOSA S.A. DE C.V.
boulevard montebello #1
parque industrial colonial
reynosa, tamualipas
MEXICO
Manufacturer Contact
mary edwards, vp
1625 west third street
po box 1740
tempe , AZ 85281
(480) 303 -2640
Device Event Key491772
MDR Report Key502999
Event Key477023
Report Number2020394-2003-50020
Device Sequence Number1
Product CodeKNW
Report Source Manufacturer
Source Type User facility
Reporter Occupation RISK MANAGER
Type of Report Initial
Report Date 12/03/2003
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/23/2003
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device Catalogue NumberC2016A
Device LOT Number22GN6241
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location Hospital
Date Manufacturer Received12/03/2003
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
Is the Device an Implant? No
Is this an Explanted Device? No Answer Provided
Type of Device Usage Initial

Database last updated on January 30, 2009

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