FDA Adverse Event Other Summary report: N

POWER PORT IMPLANTABLE ACCESS PORT

MDR report key: 2759809 · Received September 25, 2012

Report

Report Number
MW5027021
Event Type
Other
Date Received
September 25, 2012
Manufacturer
BARD ACCESS SYSTEMS
Product Code
LJT
Report Source
Voluntary report
Reporter Location
ID, US
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

ON (B)(6) 2011, (B)(6) PLACED A POWER PORT ACCESS PORT MANUFACTURED BY BARD ACCESS SYSTEMS INTO MY LEFT CHEST WALL FOR THE PURPOSE OF THE ADMINISTRATION OF CHEMOTHERAPY. THE FIRST TIME THE NURSE AT (B)(6) TRIED TO ACCESS THE PORT SHE WAS UNABLE TO. I WAS TAKEN TO X-RAY AT (B)(6) HOSP WHERE A PROCEDURE WAS DONE TO VERIFY THAT THERE WAS A PROBLEM. IT WAS DETERMINED THAT THE PORT WAS DEFECTIVE. I WAS TAKEN BACK INTO SURGERY AT (B)(6) ON (B)(6) 2011 TO HAVE THE DEFECTIVE DEVICE REPLACED. [AGE GROUP: (B)(6)]. LOST MONEY BECAUSE OF THIS PURCHASE, (B)(6). BARD ACCESS WAS THE MFR OF THE DEFECTIVE DEVICE, SO I BELIEVE THEY SHOULD BE RESPONSIBLE FOR PAYMENT OF ALL THE MEDICAL CHARGES. PAY FOR MY PAIN AND SUFFERING AND ACKNOWLEDGE THEIR DEFECTIVE DEVICE SO OTHERS WILL KNOW THE RISK OF USING A BARD ACCESS DEVICE.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 POWER PORT IMPLANTABLE ACCESS PORT IMPLANTABLE ACCESS PORT LJT BARD ACCESS SYSTEMS

Patients

Seq Age Sex Outcome Treatment
1