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Adverse Event Report

BARD ACCESS SYSTEMS HICKMAN, BROVIAC, OR LEONARD VASCULAR ACCESS CATHETER   back to search results
Lot Number 43LLP018
Event Description

Had six different catheters rupture distal to insertion site. Found product to have pin size holes that came from manufacturer. Manufacturer was notified and all products with that lot # were removed from stock. No further incidents.

 
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Brand NameHICKMAN, BROVIAC, OR LEONARD
Type of DeviceVASCULAR ACCESS CATHETER
Baseline Device 510(K) Number
Baseline Device PMA Number
Manufacturer (Section D)
BARD ACCESS SYSTEMS
5425 west amelia earhart dr
salt lake city UT 84116
Device Event Key434630
MDR Report Key445654
Event Key421940
Report NumberMW1027664
Device Sequence Number1
Product CodeDQO
Report Source Voluntary
Report Date 02/25/2003
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/25/2003
Is This An Adverse Event Report? No
Device Operator Health Professional
Device LOT Number43LLP018
OTHER Device ID NumberPRODUCT CODE 0600604
Was Device Available For Evaluation? Yes
Is the Device an Implant? Yes
Is this an Explanted Device?

Database last updated on January 30, 2009

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