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Adverse Event Report

BARD BARDPORT VASCULAR ACCESS   back to search results
Model Number 0603140 PRODUCT CODE
Device Problems Disconnect; Migration
Event Date 07/17/1998
Patient Outcome  Required Intervention;
Event Description

Right groin port-a-cath placement 3/4/98. X-ray on 7/12/98 indicates "radiopaque wire over right heart/superior mediastinum. " on 7/17/98 successful removal of right atrial free catheter which had dislodged from rt groin port-a-cath with the use of a snare.

 
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Brand NameBARDPORT
Type of DeviceVASCULAR ACCESS
Baseline Device 510(K) Number
Baseline Device PMA Number
Manufacturer (Section F)
BARD
5425 west amelia earheart
salt lake city UT 84116
Manufacturer (Section D)
BARD
5425 west amelia earheart
salt lake city UT 84116
Device Event Key187959
MDR Report Key193438
Event Key181843
Report Number193438
Device Sequence Number1
Product CodeLJT
Report Source User Facility
Reporter Occupation RISK MANAGER
Type of Report Initial
Report Date 10/20/1998
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/22/1998
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device MODEL Number0603140 PRODUCT CODE
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA10/20/1998
Distributor Facility Aware Date07/17/1998
Event Location Hospital
Date Report TO Manufacturer10/20/1998
Is the Device an Implant? Yes
Is this an Explanted Device?

Patient TREATMENT DATA
Date Received: 10/22/1998 Patient Sequence Number: 1
#TreatmentTreatment Date
1 CATHETER REMOVED 7/17/98. 07/17/1998

Database last updated on January 30, 2009

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