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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS, INC. POWERPORT DUO M.R.I. IMPLANTABLE PORT; PORT CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
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BARD ACCESS SYSTEMS, INC. POWERPORT DUO M.R.I. IMPLANTABLE PORT; PORT CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR Back to Search Results
Model Number 5829502
Device Problems Break (1069); Nonstandard Device (1420)
Patient Problem Extravasation (1842)
Event Date 01/22/2021
Event Type  malfunction  
Event Description
Right ij bard 9.5 fr double lumen powerport placed twelve weeks ago.Of note, patient experienced a "pop" during ct contrast injection a week after implant, subsequent nuclear flow study a week after that was positive for lateral lumen extravasation.Patient requires long term venous access for chemotherapy, so she underwent right port removal and placement of a new double lumen port a day after the flow study.Manufacturer response for powerport, bard 9.5 french polyurethane double lumen powerport duo port (per site reporter): no response to date.Device lot part of recall dated 3/25/21.
 
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Brand Name
POWERPORT DUO M.R.I. IMPLANTABLE PORT
Type of Device
PORT CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
Manufacturer (Section D)
BARD ACCESS SYSTEMS, INC.
605 north 5600 west
salt lake city UT 84116
MDR Report Key11626879
MDR Text Key244195037
Report Number11626879
Device Sequence Number1
Product Code LJT
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 04/01/2021
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 No Information
Device Model Number5829502
Device Catalogue Number5829502
Device Lot NumberREEV2356
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/01/2021
Device Age1 MO
Event Location Outpatient Diagnostic Facility
Date Report to Manufacturer04/07/2021
Initial Date Manufacturer Received Not provided
Initial Date FDA Received04/07/2021
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age18250 DA
Patient Weight123
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