BARD® ELLIK EVACUATOR

Additional Manufacturer Narrative

THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. UDI FORMAT UPDATED WITH AVAILABLE PRODUCT INFORMATION PER GUDID. H11: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD.

Description of Event or Problem

IT WAS REPORTED THAT THEY REQUIRED FURTHER CLARIFICATION REGARDING THE PRESENCE OF PHTHALATES IN THIS PRODUCT 000451. THE INFORMATION PROVIDED IN 2021 INDICATED THAT THIS PRODUCT DID NOT CONTAIN PHTHALATES. THEY THEREFORE NEED TO UNDERSTAND HOW AND WHY THE INCORRECT INFORMATION WAS PROVIDED. THEY WILL HAVE OUR QUALITY AND REGULATORY TEAMS PRESENT IN THE CALL WHO WOULD LIKE TO RAISE SOME ADDITIONAL QUESTIONS TO HELP US UNDERSTAND THE PROCESS. PER MDD THIS SYMBOL WOULD HAVE BEEN REQUIRED TO BE ON THE LABEL PER ERC 7.5 AS SHOWN BELOW BUT IT WAS NOT INCLUDED FOR SOME REASON. IT COULD BE THAT THE TRACKED MATERIAL IS NOT ACCURATE FOR THE END ITEM AS IT APPEARS TO NOT HAVE PVC OR PHTHALATES TRACKED MARKED. THEREFORE, THIS DEVICE WOULD HAVE BEEN CONSIDERED MISLABELED UNDER MDD. COULD SEE WHERE THIS POSSIBLY COULD BE A SA FOR THIS TYPE OF ERROR AND NEED QUALITY INVOLVEMENT. WE HAVE REALIZED THAT OUR MDD LABELS WERE OUT OF COMPLIANCE AND NEED TO REPORT THIS COMPLAINT. THE DATE OF AWARENESS IS FEB 25, 2025. AS THIS IS THE DATE WE FOUND THAT THE LABELS WERE OUT OF COMPLIANCE. THE ORIGINAL QUESTIONS CAME IN FROM A SUPPLIER ASKING ABOUT WHAT MATERIALS WERE IN OUR PRODUCTS AND THIS WAS NOT REPORTED AS A COMPLAINT. PLEASE DO NOT CONTACT THIS SUPPLIER AS WE ARE TAKING THIS THROUGH OUR FIELD ACTION COMMITTEE AND WILL CONTACT THEM DIRECTLY AFTER THE DECISION HAS BEEN MADE. THE COMPLAINANT HAS 25 TRAYS THAT ARE MDD. THIS WILL BE AN OCCURRENCE OF 25 AND NOT 25 SEPARATE COMPLAINTS.