MEDEX EXTENSION SETS SINGLE LINE

Additional Manufacturer Narrative

THIS COMPLAINT WAS INCORRECTLY FILED UNDER THIS REGISTRATION NUMBER, PLEASE REFERENCE MRN XXXXXXXX-2025-00XXX FOR DETAILS PERTINENT TO THIS EVENT.

Additional Manufacturer Narrative

H6. INVESTIGATION CODES: UPDATED. INVESTIGATION SUMMARY: RECEIVED ONE (1) USED LIST# MX448HFB, NON-DEHP EXT SET 1.2 MICRON FILTER. AS RECEIVED, THERE WERE NO DAMAGES OR ANOMALIES OBSERVED. THE SAMPLE WAS LEAK TESTED AT 20 PSI USING A HYDROSTATIC PRESSURE PUMP. A LEAK WAS OBSERVED AT THE SECOND AIR FILTER OUTLET BEFORE THE OUTLET TUBING. THE COMPLAINT OF LEAKAGE CAN BE CONFIRMED. THE PROBABLE CAUSE IS DUE TO THE FILTER'S LOSS OF HYDROPHOBIC PROPERTIES. A DEVICE HISTORY RECORD COULD NOT BE COMPLETED AS NO LOT NUMBER WAS RECEIVED.

Additional Manufacturer Narrative

A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE.

Description of Event or Problem

IT WAS REPORTED THAT THE LIPID FILTER WAS LEAKING WHILE CONNECTED TO PICC LINE. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.