MEDEX IV FILTER EXTENSION SET 25/CA25/CA

Additional Manufacturer Narrative

H3 AND H6. EVALUATION CODES: UPDATED. THROUGH DEVICE ANALYSIS THE COMPLAINT WAS VERIFIED. DURING VISUAL INSPECTION IT WAS OBSERVED THAT THE THREE (3) RETURNED SAMPLES EXHIBITED LACK OF SOLVENT BETWEEN THE BONDING UNION OF TUBE AND FILTER. A SUSPECTED ROOT CAUSE WAS LACK OF SOLVENT DURING MANUFACTURING/ASSEMBLY. AWARENESS FOR THE FAILURE MODE WAS GIVEN TO PERSONNEL WHO PERFORM THE ASSEMBLY PROCESS. THE COMPLAINT FAULT HAS BEEN ESCALATED TO ADDRESS A FULL ROOT CAUSE INVESTIGATION. A DEVICE HISTORY RECORD (DHR) REVIEW REPORTED NO DISCREPANCIES OR NON-CONFORMANCE'S DURING THE MANUFACTURING OF THE REPORTED LOT NUMBER.

Description of Event or Problem

IT WAS REPORTED THAT FLUID LEAKS OUT OF THE TUBING DURING IV INFUSION. THERE WAS PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM REPORTED.

Additional Manufacturer Narrative

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.