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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS, INC. VACCESS CT LOW-PROFILE POWER-INJECTABLE IMPLANTABLE PORT; PORT CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
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BARD ACCESS SYSTEMS, INC. VACCESS CT LOW-PROFILE POWER-INJECTABLE IMPLANTABLE PORT; PORT CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR Back to Search Results
Model Number 7380000
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 10/24/2018
Type of Reportable Event Malfunction
Event or Problem Description
Pt had a port-a-cath placed.It was found to have become disconnected via imaging.Thirteen days later, the catheter portion of the pac was removed and one week after that, the port itself was removed and replaced with a new device.
 
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Brand Name
VACCESS CT LOW-PROFILE POWER-INJECTABLE IMPLANTABLE PORT
Common Device Name
PORT CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
Manufacturer (Section D)
BARD ACCESS SYSTEMS, INC.
605 north 5600 west
salt lake city UT 84116
MDR Report Key8054640
Report Number8054640
Device Sequence Number13879640
Product Code LFJ
UDI-Device Identifier00801741027451
UDI-Public(01)00801741027451
Combination Product (Y/N)N
Initial Reporter StateME
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
Device Explanted Year2018
Reporter Type User Facility
Initial Reporter Occupation Risk Manager
Type of Report Initial
Report Date (Section B) 11/02/2018
Report Date (Section F) 11/02/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this a Product Problem Report? Yes
Operator of Device No Information
Device Model Number7380000
Device Catalogue Number7380000
Device Lot NumberRECV0264
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? Yes
Event Location Hospital
Date Report to Manufacturer11/09/2018
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date11/09/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Patient Weight65
Date Report Sent to FDA11/02/2018
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