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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS, INC. POWERPORT ISP M.R.I. IMPLANTABLE PORT; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
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BARD ACCESS SYSTEMS, INC. POWERPORT ISP M.R.I. IMPLANTABLE PORT; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR Back to Search Results
Model Number 1808560
Device Problems Difficult to Flush (1251); Therapeutic or Diagnostic Output Failure (3023)
Patient Problem Foreign Body In Patient (2687)
Event Date 12/15/2016
Event Type  malfunction  
Event Description
Powerport that reportedly stopped working in 2016.Difficulty with flushes and c/o pain.Inspection of the powerport post procedure revealed that the only a 1 cm segment of the 8-french groshong catheter was present, attached to the powerport, around the powerport joint.The chest x-ray revealed that the 8-french groshong catheter was present in the right ventricle.Patient transferred to higher level of care for emergent removal of the retained foreign body.
 
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Brand Name
POWERPORT ISP 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 Key12293279
MDR Text Key265573505
Report Number12293279
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 Other Health Care Professional
Type of Report Initial
Report Date 08/04/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/09/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model Number1808560
Device Catalogue Number1808560
Device Lot NumberREVH2657
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/04/2021
Event Location Hospital
Date Report to Manufacturer08/09/2021
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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