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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD POWER PORT SET, ADMINISTRATION, INTRAVASCULAR

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BARD POWER PORT SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Lot Number REBT0025
Device Problems Crack (1135); Leak/Splash (1354)
Patient Problems Chest Pain (1776); Pain (1994); Neck Pain (2433)
Event Date 12/11/2017
Event Type  Injury  
Event Description
On (b)(6) i went for my third chemotherapy treatment and over the next few days after i began to feel horrible pain in my chest, neck and right shoulder. After calling my doctor a number of times telling them something was wrong i was sent for port study and the radiologist found the catheter was cracked and leaking into my chest. The pain at this point was so bad i could not lie down and i kept calling my doctor begging for help. Finally on (b)(6) i had surgery to remove the broken port and a new one implanted. I was hopeful that would have stopped the pain but it did not and in fact it only got worse. I was then admitted to the hospital and treated with high doses of antibiotics and pain medication for four days. I was sent home with antibiotics and pain medication but the pain was still unbearable. On (b)(6) i had an appointment with my oncologist and when i told him i was still in so much pain and had still not been able to lie down since about (b)(6) he sent me for another port check on the new port that was implanted. The new port would not give blood through it but could receive the chemotherapy. I had another chemotherapy treatment on (b)(6) and when i saw my oncologist this day and told him i was still in so much pain he sent me for an mri. I had my mri on (b)(6) at 5:30 pm and received a call the next day to go straight to the hospital. I was again admitted for another 3 days and treated with high dose antibiotics and pain medication.
 
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Brand NamePOWER PORT
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
BARD
MDR Report Key7402261
MDR Text Key104698097
Report NumberMW5076353
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 04/04/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/05/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date09/30/2018
Device Lot NumberREBT0025
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 04/05/2018 Patient Sequence Number: 1
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