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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS, INC. BARD POWER PORT CLEARVUE ISP IMPLANTABLE PORT 8F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
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BARD ACCESS SYSTEMS, INC. BARD POWER PORT CLEARVUE ISP IMPLANTABLE PORT 8F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR Back to Search Results
Model Number 1668362
Device Problem Material Erosion (1214)
Patient Problems Erythema (1840); Tissue Breakdown (2681)
Event Date 04/28/2020
Event Type  Injury  
Event Description
A bard power port clearvue isp implantable port (#1668362) was implanted by interventional radiology on (b)(6) 2020.On (b)(6) 2020 it was noted the port had eroded through the skin.Upon inspection it was noted that the cranial half of the reservoir was visible with skin breakdown and erythema around the healed incision.There was no evidence of infection.No swelling or drainage was present.The port was removed by the interventional radiologist, the wound was closed, and the patient was placed on antibiotics.This is 1 of 2 similar events with this product.Fda safety report id # (b)(4).
 
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Brand Name
BARD POWER PORT CLEARVUE ISP IMPLANTABLE PORT 8F
Type of Device
PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
Manufacturer (Section D)
BARD ACCESS SYSTEMS, INC.
MDR Report Key10188898
MDR Text Key196413386
Report NumberMW5095163
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 Voluntary
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 06/19/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number1668362
Device Catalogue Number1668362
Device Lot NumberREDX1701
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/28/2020
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received06/23/2020
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) Other; Required Intervention;
Patient Age28 YR
Patient Weight91
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