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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS, INC. VAS-CATH VACCESS CT POWER INJECTABLE IMPLANTABLE PORT; PORTA CATHETER
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BARD ACCESS SYSTEMS, INC. VAS-CATH VACCESS CT POWER INJECTABLE IMPLANTABLE PORT; PORTA CATHETER Back to Search Results
Lot Number RECW1007
Device Problems Material Separation (1562); Detachment of Device or Device Component (2907); Migration (4003)
Patient Problems Chest Pain (1776); Dizziness (2194); Foreign Body In Patient (2687)
Event Date 12/29/2018
Event Type  Injury  
Event Description
Pt s/p porta-cath placement for chemotherapy on (b)(6) 2018.Pt seen in ed on (b)(6) 2018 for chest pain, dizziness and sob.Cta pulmonary revealed tubing split from the porta-cath site.The port was in correct place; however, the tubing migrated down and into the chest and coiled in the right ventricle.Emergent transfer to tertiary facility for tubing retrieval.Removal of chest port and catheter was successful and pt was discharged from tertiary facility on (b)(6).
 
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Brand Name
VAS-CATH VACCESS CT POWER INJECTABLE IMPLANTABLE PORT
Type of Device
PORTA CATHETER
Manufacturer (Section D)
BARD ACCESS SYSTEMS, INC.
605 north 5600 west
salt lake city UT 84116
MDR Report Key8230765
MDR Text Key132521441
Report Number8230765
Device Sequence Number1
Product Code LJT
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 01/02/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/03/2019
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date11/19/2019
Device Lot NumberRECW1007
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/02/2019
Distributor Facility Aware Date12/31/2018
Event Location Hospital
Date Report to Manufacturer01/02/2019
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age30 YR
Patient Weight93
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