FDA Adverse Event Malfunction Summary report: N

THERMOFISHER EPREDIA

MDR report key: 9523341 · Received December 27, 2019

Report

Report Number
9523341
Event Type
Malfunction
Date Received
December 27, 2019
Date of Event
December 14, 2019
Report Date
December 24, 2019
Manufacturer
THERMO FISHER SCIENTIFIC INC.
Product Code
IDZ
Product Problem
Yes
Report Source
User Facility report
Reporter Location
IL
Reporter Occupation
OTHER HEALTH CARE PROFESSIONAL

Narratives

Description of Event or Problem · 1

WE HAVE WHAT APPEARS TO BE A NEW BIOPSY CASSETTE IN YELLOW. THE LIDS DO NOT FIT PROPERLY ON THESE CASSETTES AND WE ARE EXPERIENCING LOOSE CLOSURE AND THE POSSIBILITY OF TISSUE FREE FLOATING DURING PROCESSING. IT APPEARS THE NEWER CASSETTES ARE LIGHTER IN COLOR THAN OUR ORIGINAL ONES. ALSO NEITHER THE OLDER LIDS NOR THE ONES THAT ARE SUPPOSED TO BE THE COMPANION TO THE LIGHTER COLORED CASSETTES IS FITTING. I AM HIGHLY CONCERNED ABOUT CASE INTEGRITY AND PATIENT SAFETY WITH THIS HAPPENING. THIS IS A SERIOUS ISSUE WHEN CONSIDERING THE INTEGRITY OF THE TISSUE, CASE, AND PROVIDING ACCURATE PATIENT RESULTS. (ABOVE INFORMATION WAS FROM LAB DIRECTOR) THESE SAMPLES ARE IRRETRIEVABLE. SO IF WE COMPROMISE IDENTITY, WE LOSE THE ABILITY TO DIAGNOSE. OFTEN THERE IS NO ADDITIONAL TISSUE TO GO BACK TO. MANUFACTURER RESPONSE FOR TISSUE CASSETTE, (BRAND NOT PROVIDED) (PER SITE REPORTER). HI ALL, THIS IS VERY CONCERNING AND I CERTAINLY UNDERSTAND THE GRAVITY OF THIS SITUATION. I'M COPYING [] ON THIS MESSAGE AS SHE REPRESENTS THE MANUFACTURER AND NEEDS TO BE INCLUDED HERE. ALL OF THE CASSETTES¿BIOPSY AND SLOTTED IN ALL COLORS ARE CHANGING TO THE NEW PART NUMBERS. THIS HAS BEEN TAKING PLACE GRADUALLY OVER THE PAST FEW MONTHS, WITH THE MAJORITY OF CHANGES OCCURRING OVER THE PAST FEW WEEKS. SOME COLORS WERE ELIMINATED (AS YOU KNOW), BUT OTHERWISE, THIS TRANSITION WAS TO BE SEAMLESS. I'M LISTING ALL OF YOUR PREVIOUS PART NUMBERS ALONG WITH THE REPLACEMENT PART NUMBERS BELOW. HAVE YOU STARTED USING ANY OF THESE NEW CASSETTES IN OTHER STYLES/COLORS? I'D LIKE TO DETERMINE IF THE YELLOW PART NUMBER IS THE ONLY PROBLEMATIC COLOR OR IF THIS IS MORE WIDESPREAD. ALL OF THE NEW PART NUMBERS BEGIN WITH "B851......". (EMAIL RESPONSE FROM [], THERMOFISHER SALES REP).

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1318689 THERMOFISHER EPREDIA TISSUE CASSETTE IDZ THERMO FISHER SCIENTIFIC INC. I17C9Q1

Patients

Seq Age Sex Outcome Treatment
1