MICRO-VOLUME EXTENSION SET

Additional Manufacturer Narrative

H10: AN ONSITE VISIT WAS PERFORMED, AND IT WAS DETERMINED THAT REPORTED CONDITION OF FILTER LEAKS WERE RELATED TO THE END USER/CONDITION EXCEEDING THE MANUFACTURING SPECIFICATION (PRESSURE) AND/OR MATERIAL COMPATIBILITY (MEDICINE/SOLUTION) OF THE FILTER. LABELING INFORMATION REGARDING THE FILTER LEAK WAS REVIEWED. THE CAUSE OF THE REPORTED CONDITION WAS A USER ERROR. THE LABELING OF THE PRODUCT CAUTIONS THE USER THAT THE INTERNAL PRESSURE SHOULD NOT EXCEED 45 PSI. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Additional Manufacturer Narrative

SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Description of Event or Problem

IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF A NON-DEHP MICRO-VOLUME EXTENSION SETS LEAKED AT THE FILTER. THE ISSUE WAS IDENTIFIED DURING PATIENT INFUSION. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

Additional Manufacturer Narrative

H10: TWENTY-ONE (21) ACTUAL SAMPLES WERE RECEIVED FOR EVALUATION. VISUAL INSPECTION WAS PERFORMED AND ALL COMPONENTS WERE OBSERVED CORRECTLY PLACED AND ACCORDING TO SPECIFICATIONS. A FUNCTIONAL TESTING WAS PERFORMED INCLUDING CLEAR PASSAGE AND PRESSURE TESTING AND NO BLOCKAGE WAS OBSERVED. HOWEVER, DURING PRESSURE TEST A LEAK WAS OBSERVED IN THE AIR VENT OF THE FILTER OF THE SIX (6) SAMPLES ONLY. THE REPORTED CONDITION WAS VERIFIED IN THE SIX (6) SAMPLES; HOWEVER, NOT VERIFIED IN THE REMAINING FIFTEEN (15) SAMPLES. THE CAUSE OF THE CONDITION WAS DUE TO MANUFACTURING RELATED ISSUE. THIS ISSUE IS BEING FURTHER INVESTIGATED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.