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Adverse Event Report

BARD ACCESS SYSTEMS BROVIAC CATHETER LONG TERM INTRAVASCULAR CATHETER   back to search results
Device Problems Device breakage; Implant, removal of
Event Date 04/01/2002
Event Type  Injury   Patient Outcome  Required Intervention;
Event Description

2. 7 fr. Catheter placed in 2001, was used for infusion of meds. Catheter was initially inserted in the saphenous vein, then 7 months the pt required a feeding tube & broviac was removed because it was no longer needed. During x-ray in 2002, a fragment of the catheter was detected in the ivc. The pt experience no injury.

 
Manufacturer Narrative

Findings: no product returned for eval, inconclusive. Complaint history not possible, as no lot number was provided.

 
Search Alerts/Recalls

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Brand NameBROVIAC CATHETER
Type of DeviceLONG 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
bryn ball, mgr.
5425 west amelia earhart dr.
salt lake city , UT 84116
(801) 595 -0700
Device Event Key417412
MDR Report Key428392
Event Key405269
Report Number1720496-2002-00225
Device Sequence Number1
Product CodeDQO
Report Source Manufacturer
Source Type Other
Reporter Occupation Other
Type of Report Initial
Report Date 10/11/2002
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/12/2002
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/07/2002
Distributor Facility Aware Date08/01/2002
Device Ageno info
Event Location Hospital
Date Report TO Manufacturer10/11/2002
Date Manufacturer Received10/11/2002
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is the Device an Implant? Yes
Is this an Explanted Device?
Type of Device Usage Unkown

Database last updated on February 28, 2009

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