Description of Event or Problem · 1
REGARDING BARD ACCESS SYSTEMS, INC. POWER PORT ISP M.R.I. DEVICE WITH 8.0 INCH FRENCH CHRONO FLEX CATHETER - BARD PRODUCT NO. 1808069- PROBLEM WITH A LEAK IN THE CATHETER: THE ORIGINAL POWER PORT WAS IMPLANTED ON (B)(6), 2010 TO FACILITATE CHEMOTHERAPY. DURING A CHEMOTHERAPY SESSION IN (B)(6), THE ATTENDING NURSE IDENTIFIED A POTENTIAL ISSUE WITH THE PORT LEAKING FLUID. THAT SAME DAY, AN X-RAY OF THE PORT AREA CONCLUDED THAT THERE WAS A POTENTIALLY DANGEROUS LEAK IN THE CATHETER OF THE PORT. IT WAS DETERMINED THAT THE ORIGINAL PORT NEEDED TO BE REMOVED/REPLACED AS SOON AS POSSIBLE. ON (B)(6), I ENTERED THE HOSPITAL TO REPLACE THE 4-MONTH OLD PORT AFTER ONLY 3 USES OF THE APPARENT DEFECTIVE PRODUCT. I CALLED BARD TO ADVISE THEM OF THE ISSUE IN ORDER FOR THEM TO TAKE THE APPROPRIATE INVESTIGATIVE STEPS AS WELL AS REQUEST A NOMINAL REMUNERATION - LESS THAN (B)(6) - FOR OUT OF POCKET EXPENSES. THE CUSTOMER SERVICE AGENT - (B)(4) - ADVISED ME TO SUBMIT A LETTER DETAILING SPECIFICS. SHE FOLLOWED-UP WITH A LETTER DATED (B)(6) WHICH STATED IN PART "WE APPRECIATE YOU REPORTING THE ABOVE REFERENCED MATTER AND OFFER OUR APOLOGIES FOR ANY INCONVENIENCE THAT MAY HAVE OCCURRED FOR YOU OR YOUR HOSPITAL. WE UNDERSTAND THAT THE PRODUCT IS UNAVAILABLE FOR EVAL AT OUR FACILITY AT THIS TIME. SHOULD THIS RECUR, PLEASE SAVE THE PRODUCT AND CONTACT OUR OFFICE SO THAT WE MAY MAKE SHIPPING ARRANGEMENTS." DESPITE THE FACE THAT I PROVIDED BARD WITH THE NAME OF THE ONCOLOGIST WHOSE NURSE FIRST SUSPECTED THE LEAK, THE NAME OF THE HOSPITAL WHERE THE XRAY REVEALED THE LEAK AND WHERE AN ON-CALL PHYSICIAN CONFIRMED THE PORT NEEDED TO BE REPLACED AS WELL AS THE THORACIC SURGEON WHO INSTALLED THE ORIGINAL PORT AND THEN ITS SUBSEQUENT REPLACEMENT, BARD SIMPLY STATED "THE PRODUCT IS UNAVAILABLE FOR EVAL" WITH NO INDICATION THAT ANY ADDITIONAL ROOT CAUSE ANALYSIS WOULD BE CONDUCTED. I SENT A FOLLOW-UP LETTER ON AUGUST 10, VOICING MY DISSATISFACTION WITH THE TERSE RESPONSE THAT THE "PRODUCT WAS UNAVAILABLE" AND ALSO REQUESTED (B)(6) IN OUT-OF-POCKET EXPENSES. AFTER A NUMBER OF PHONE CALLS TO FIND OUT THE STATUS OF MY LETTER, I FINALLY RECEIVED A LETTER ON OCTOBER 14 - FROM (B)(4) - PARALEGAL - STATING "PLEASE BE ADVISED THAT BARD HAS COMPLETED ITS REVIEW OF YOUR CLAIM. WHILE WE WERE SORRY TO LEARN OF THE DIFFICULTIES YOU EXPERIENCED, A DETAILED ASSESSMENT OF YOUR CLAIM DOES NOT REVEAL A PRODUCT PROBLEM. BASED ON THE INFO PROVIDED, BARD MUST RESPECTFULLY DENY YOUR REQUEST FOR COMPENSATION." AGAIN, NO MENTION OF THE EXTENT TO WHICH BARD EVEN CONTACTED OR INTERVIEWED ANY OF THE PARTIES I MENTION ABOVE. I DO NOT EXPECT THE FDA TO ASSIST ME IN GETTING THE (B)(6). LET BARD KEEP ITS LITTLE MONIES - I DO NOT NEED THEM. HOWEVER, I AM EXTREMELY CONCERNED WITH THE SEEMINGLY NONCHALANT ATTITUDE WITH WHICH THEIR "INVESTIGATION" WAS CONDUCTED. WE ARE NOT TALKING ABOUT TOO MUCH SUGAR IN A CHILD'S SUCKER HERE. WE ARE TALKING ABOUT A MEDICAL DEVICE WHICH IS IMPLANTED SUBCUTANEOUSLY AND A CATHETER WHICH IS INSERTED INTO A MAJOR BLOOD VESSEL. HAD THAT CATHETER SEPARATED ENTIRELY, IT COULD HAVE ENTERED THE HEART WITH DISASTROUS CONSEQUENCES. I ASK THAT THE FDA REVIEW BARD'S PROCESS FOR PROBLEM REPORTING, INFO GATHERING, ROOT CAUSE ANALYSIS AND RESOLUTION TO ENSURE IT MEETS FDA STANDARDS. FROM AN OUTSIDER'S PERSPECTIVE, AT MINIMUM, BARD SHOULD PROVIDE GUIDANCE TO SURGEONS WHO REMOVE POTENTIALLY DEFECTIVE PORTS TO RETAIN THE REMOVED PORT AND SEND IT TO THE BARD FACILITY FOR EVAL. APPARENTLY, THAT IS NOT PART OF THEIR CURRENT PROCESS. DATES OF USE: (B)(6) 2010 - (B)(6) 2010. DIAGNOSIS OR REASON FOR USE: FACILITATE CHEMOTHERAPY.