MEDEX EXTENSION FILTER SETS

Additional Manufacturer Narrative

THIS FILE WAS ORIGINALLY INCORRECTLY FILED UNDER REGISTRATION NUMBER 9616567-2025-00031-00. THE DATE OF THAT SUBMISSION WAS 17-FEB-2025. DEVICE WAS RECEIVED FOR ANALYSIS. VISUAL AND FUNCTIONAL EVALUATION WAS PERFORMED A CRACK WAS OBSERVED ON THE FEMALE LUER OF THE FILTER, ALONG THE PARTING LINE. A LEAK WAS OBSERVED AT THE FEMALE LUER CONNECTION FROM THE CRACK PREVIOUSLY OBSERVED. THE LEAK WAS OBSERVED TO START AT 0.5 PSI. COMPLAINT WAS CONFIRMED. THE CAUSAL FACTOR OF FAILURE MODE CRACK AT THE FEMALE PORT OF THE BLUE FILTER WAS RELATED TO A MISHANDLING OF THE PRODUCT. DEVICE HISTORY REVIEW FOUND NO DISCREPANCIES OR ANOMALIES WERE OBSERVED DURING THE MANUFACTURING OF THIS LOT.

Description of Event or Problem

IT WAS REPORTED THAT LIPIDS STARTED LEAKING WHERE THE REGULAR IV TUBING MEETS THE LIPID FILTER ON A PCVC LINE. ALSO, THE LIPIDS LEAKED AT CONNECTION BETWEEN REGULAR BAXTER IV TUBING AND MEDEX MICRON LIPID FILTER. THERE WERE UNKNOWN PATIENT HARMS OR ADVERSE EVENTS REPORTED AS A RESULT OF THE EVENT.