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Adverse Event Report

BARD ACCESS SYSTEMS GROSHONG 4FR S/L PICC IMPLANTED LONG TERM INTRAVASCULAR CATHETER   back to search results
Device Problems Migration; Implant, removal of
Event Date 01/13/2003
Event Type  Injury   Patient Outcome  Required Intervention;
Event Description

The line detached from the hub and migrated to the lung. The catheter was removed.

 
Manufacturer Narrative

Device has been returned to the manufacturer but not yet evaluated. Complaint history review: can not be performed because a lot number was not provided.

 
Search Alerts/Recalls

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Brand NameGROSHONG 4FR S/L PICC
Type of DeviceIMPLANTED LONG TERM INTRAVASCULAR CATHETER
Baseline Device 510(K) Number
Baseline Device PMA Number
Manufacturer (Section F)
BARD ACCESS SYSTEMS
5425 west amelia earhart dr.
salt lake city UT 84116
Manufacturer (Section D)
BARD ACCESS SYSTEMS
5425 west amelia earhart dr.
salt lake city UT 84116
Manufacturer Contact
nitin patil, mgr
5425 west amelia earhart dr
salt lake city , UT 84116
(801) 595 -0700
Device Event Key432289
MDR Report Key443314
Event Key419646
Report Number1720496-2003-00023
Device Sequence Number1
Product CodeDQO
Report Source Manufacturer
Source Type Other
Reporter Occupation Other
Type of Report Initial
Report Date 01/14/2003
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/11/2003
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer02/07/2003
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date01/13/2003
Device Ageno info
Event Location Hospital
Date Report TO Manufacturer02/11/2003
Was Device Evaluated By Manufacturer? Yes
Is The Device Single Use? Yes
Is the Device an Implant? No
Is this an Explanted Device?
Type of Device Usage Unkown

Database last updated on February 28, 2009

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