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Adverse Event Report

CARDINAL HEALTH COAXIAL BIOPSY CHIBA NEEDLE   back to search results
Model Number CCH2210
Event Date 08/04/2003
Event Type  Injury   Patient Outcome  Hospitalization; Other
Event Description

Upon completion of lung biopsy, doctor connected a luer-locking syringe to the coaxial introducer, did slight aspiration then, upon withdrawal of needle, the hub of the needle and the cannula became dislodged, leaving needle cannula in deep muscle tissue of patient requiring surgery to remove.

 
Manufacturer Narrative

Information forwarded to manufacturing facility. Results pending. Follow-up report will be filed.

 
Search Alerts/Recalls

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Brand NameCOAXIAL BIOPSY CHIBA NEEDLE
Type of DeviceCOAXIAL BIOPSY CHIBA NEEDLE
Baseline Brand NameCOAXIAL BIOPSY CHIBA NEEDLE
Baseline Generic NameCOAXIAL BIOPSY CHIBA NEEDLE
Baseline Catalogue NumberCCH2210
Baseline Model NumberCCH2210
Baseline Device FamilyBIOPSY DEVICE
Baseline Device 510(K) NumberK962907
Baseline Device PMA Number
Baseline Shelf Life Information No
Baseline Preamendment? No
Transitional? No
510(K) Exempt? No
Date First Marketed10/23/1996
Manufacturer (Section F)
CARDINAL HEALTH
1430 waukegan rd.
mcgaw park IL 60085
Manufacturer (Section D)
CARDINAL HEALTH
1430 waukegan rd.
mcgaw park IL 60085
Manufacturer (Section G)
9680904/BAUER
1-2 sur
km 22, edif
santa domingo
DOMINICAN REPUBLIC
Manufacturer Contact
patricia sharpe-gregg
1430 waukegan road
mcgaw park , IL 60085
(847) 578 -4148
Device Event Key470516
MDR Report Key481630
Event Key456531
Report Number1423507-2003-00112
Device Sequence Number1
Product CodeKNW
Report Source Manufacturer
Source Type Health Professional,User facility
Reporter Occupation RISK MANAGER
Type of Report Initial
Report Date 09/04/2003
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/04/2003
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device MODEL NumberCCH2210
Device Catalogue NumberCCH2210
Device LOT NumberD01AB0731
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received08/05/2003
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured01/01/2001
Is The Device Single Use? Yes
Is the Device an Implant? No
Is this an Explanted Device? Unknown
Type of Device Usage Initial

Database last updated on January 30, 2009

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