Q2 T-EXTENSION SET, 7 INCH

Additional Manufacturer Narrative

TWO (2) USED SAMPLES AND EIGHT (8) UNUSED SAMPLES WERE RECEIVED FROM THE CUSTOMER FOR EVALUATION. ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER INDICATED THE ALLEGED DEFECT FOR THE FIRST USED SAMPLE AS LEAKING AND THE ALLEGED DEFECT FOR THE SECOND SAMPLE AS DIFFICULTY FLUSHING THE PORT. THE 8 UNUSED SAMPLES WERE DUNK TESTED AT 45 PSI PRESSURE FOR 1 MIN AND NO LEAKAGE WAS OBSERVED AS THE SAMPLES ALL FUNCTIONED AS INTENDED. DURING EVALUATION OF THE USED SAMPLE WHICH WAS ALLEGED TO HAVE ISSUES WITH FLUSHING THE PORT, INCREASED RESISTANCE WAS OBSERVED AS A RESULT OF THE PRESENCE OF TWO CHECK VALVES INSTEAD OF ONE PER THE DEVICE SPECIFICATIONS. THE ROOT CAUSE OF THE INCREASED RESISTANCE TO FLUSH THE PORT IS ASSEMBLY ERROR. NO CORRECTIVE ACTION IS BEING TAKEN AT THIS TIME FOR THIS DEFECT, AS THIS IS AN ISOLATED OCCURRENCE. QUEST WILL CONTINUE TO MONITOR COMPLAINTS FOR TRENDS TO RE-EVALUATE THE NEED FOR A CORRECTIVE ACTION. DURING EVALUATION OF THE SAMPLE WHICH WAS ALLEGED TO HAVE LEAKED, NO LEAKAGE WAS IDENTIFIED DURING THE DECONTAMINATION PROCESS. FOLLOWING DECONTAMINATION, THE SAMPLE WAS CONNECTED TO A WATER INLET I WITH THE OPEN ENDS CAPPED AND WATER WAS RUN THROUGH THE MANIFOLD FOR APPROXIMATELY 6 HOURS. NO LEAKAGE WA SEEN AT THE PORT WHICH WAS IDENTIFIED BY THE CUSTOMER AS LEAKING. LEAKAGE WAS HOWEVER SUBSEQUENTLY SEEN COMING FROM CRACKS ON ONE OF THE DOUBLE T-SITES. FURTHER INVESTIGATION REVEALED THAT THE CRACKS, WHERE LEAKING WAS OBSERVED, RESULTED FROM THE USE OF BLEACH IN DECONTAMINATING THE DEVICE AT QUEST MEDICAL BEFORE THE DEVICE EVALUATION. THE POINT OF LEAKAGE ALLEGED BY THE CUSTOMER COULD NOT BE CONFIRMED AS MANUFACTURING RELATED.

Description of Event or Problem

A REPORT WAS RECEIVED REGARDING AN ALLEGED ISSUE ENCOUNTERED WITH THE Q2 T-EXTENSION SET. THE REPORT STATES THAT THE CUSTOMER'S FACILITY EXPERIENCED LEAKING PORTS ON 5 OF THE EXTENSION SETS WITHIN A 24 HOUR PERIOD. ACCORDING TO THE CUSTOMER, ONE OF THE PATIENTS ON WHOM THE LEAKING DEVICE WAS USED, HAD TO BE GIVEN FLUID AND INOTROPIC RESUSCITATION DUE TO THE EPI LEAKING OUT WHILE ANOTHER PATIENT HAD TO BE GIVEN EXTRA BOLUSES DUE TO THE SEDATION GTTS LEAKING.