MEDEX EXTENSION FILTER SETS

Additional Manufacturer Narrative

ONE (1) USED DECONTAMINATED SAMPLE OUTSIDE ITS ORIGINAL PACKAGE WAS RECEIVED. VISUAL INSPECTED NOTED A CRACK AT THE FEMALE PORT OF THE BLUE FILTER. A FUNCTIONAL LEAK TEST WAS PERFORMED, AND A LEAKAGE WAS OBSERVED AT THE LUER CONNECTOR FROM FILTER. THE COMPLAINT WAS CONFIRMED. THE ROOT CAUSE WAS DUE TO THE OBSERVED CRACK CAUSED BY MISHANDLING OF THE PRODUCT BY THE CUSTOMER. A DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER WAS UNKNOWN. NO FURTHER ACTION WAS TAKEN AS CURRENT CONTROLS ARE ADEQUATE AND THE FAILURE WAS DUE TO THE CUSTOMER MISHANDLING THE DEVICE.

Additional Manufacturer Narrative

OTHER, OTHER TEXT: B3: DATE OF EVENT, D4: LOT NUMBER, EXPIRATION DATE, UDI NUMBER AND H4: DEVICE MANUFACTURE DATE IS UNKNOWN, NO INFORMATION HAS BEEN PROVIDED TO DATE. INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. 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 THERE WAS A CRACK IN THE FEMALE LUER PART OF THE BLUE FILTER. THE RN HAD DONE A ROUTINE LINE CHANGE FOR LIPIDS AT AROUND 0900. THERE HAD BEEN NO OVER-TIGHTENING OR ANY OTHER MANIPULATION OF THE LINE OR TUBING THROUGHOUT THE DAY. IN THE EVENING, IT WAS DISCOVERED BLOOD BACKING UP IN THE LINE AND SUBSEQUENTLY NOTED LIPIDS LEAKING, AT WHICH POINT THE CRACK WAS DISCOVERED. ADVERSE PATIENT EFFECTS ARE UNKNOWN.