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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS, INC. POWERPORT M.R.I. IMPLANTABLE PORT; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
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BARD ACCESS SYSTEMS, INC. POWERPORT M.R.I. IMPLANTABLE PORT; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR Back to Search Results
Model Number 1808000
Device Problem Improper or Incorrect Procedure or Method (2017)
Patient Problems Chest Pain (1776); Patient Problem/Medical Problem (2688)
Event Date 12/13/2018
Event Type  Injury  
Event Description
[date redacted] power port placement in the hospital's operating room.Three days later: patient received first chemotherapy infusion doxorubicin and cytoxan.Patient complained of chest pain post chemotherapy experienced during flushing post chemotherapy.Chest tube placed.Next day: power port removed from patient.Based on radiology studies and physician assessment, appears the chemotherapy was administered into the patient's lung.
 
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Brand Name
POWERPORT 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 Key8193681
MDR Text Key131308568
Report Number8193681
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 12/20/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/24/2018
Is this an Adverse Event Report? Yes
Device Operator Health Professional
Device Model Number1808000
Device Catalogue Number1808000
Device Lot NumberRECU1598
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/20/2018
Event Location Outpatient Treatment Facility
Date Report to Manufacturer12/24/2018
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age24090 DA
Patient Weight93
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