MEDEX EXTENSION SETS SINGLE

Description of Event or Problem

IT WAS REPORTED THAT THERE WAS LEAKING ABOVE THE FILTER. NO ADVERSE EFFECTS REPORTED.

Additional Manufacturer Narrative

THIS MDR WAS GENERATED UNDER PROTOCOL (B)(4), AS A RESULT OF WARNING LETTER CMS# (B)(4). NO PROBLEMS OR ISSUES WERE IDENTIFIED DURING THIS DEVICE HISTORY RECORD REVIEW A PRODUCT SAMPLE WAS RECEIVED FOR EVALUATION. VISUAL AND FUNCTIONAL TESTING WERE PERFORMED. SIX USED SAMPLES WERE RECEIVED OUTSIDE ITS ORIGINAL PACKAGE. THE RETURNED SAMPLES WERE TESTED AT 20 POUNDS PER SQUARE INCH (PSI) FOR WATER LEAK ACCORDING TO PROCEDURE. ALL SIX SAMPLES EXHIBITED LEAKAGE CONDITION AT THE FILTER AND AT THE BONDING OF TUBE. THE BONDING OF TUBE WAS INSPECTED. THE TECHNICIAN OBSERVED LACK OF SOLVENT ON THE BONDING OF TUBE. THE ROOT CAUSE OF THE REPORTED ISSUE WAS FOUND TO BE LEAKAGE AT THE FILTER WAS RELATED TO A SUPPLIER ISSUE. A SUPPLIER CORRECTIVE ACTION REPORT HAS BEEN WAS ISSUED TO ADDRESS THE REPORTED ISSUE. MANUFACTURING PROCESS WAS REVIEWED, IT WAS OBSERVED FIXTURE WAS USE TO AVOID OCCLUSION DEFECT BY LETTING POSITIVE AIR PRESSURE FLOW INSIDE THE TUBE, WHEN DIPPING INTO THE SOLVENT, IN ORDER TO AVOID THE SOLVENT GETTING TOUCH WITH THE INTERNAL WALLS OF THE TUBE AND CAUSING OCCLUSION. ACCORDING TO MANUFACTURING ROUTINE, THE POSITIVE AIR PRESSURE OF THE FIXTURE MUST BE SET AT 0.021 +/- 0.003 MEGAPASCALS (MPA), IT WAS OBSERVED THAT THE MANOMETER USED DOES NOT HAVE THE CORRECT RESOLUTION AND THEREFORE THE OPERATOR COULD NOT TO SET ACCORDINGLY. IT WAS CONCLUDED THAT THE MOST LIKELY ROOT CAUSE OF LACK OF SOLVENT DEFECT, WAS RELATED TO THE AIR PRESSURE NOT BEING SET TO ESTABLISHED PRESSURE RANGE AND CAUSING THE AIR TO PRODUCED A LOT OF BUBBLES AND MAKING DIFFICULT FOR THE OPERATOR TO OBSERVED IF THE EXTERNAL WALLS OF THE TUBE WERE TOTALLY IMPREGNATED OF SOLVENT. THE MANOMETER WAS CHANGED TO A DIGITAL TYPE THAT DISPLAY AN ACCURATE AIR PRESSURE. A SUPPLIER CORRECTIVE ACTION REPORT HAS BEEN WAS ISSUED TO ADDRESS THE REPORTED ISSUE. AWARENESS MEETING WITH OPERATORS AND QUALITY INSPECTORS ABOUT THE FAILURE MODE REPORTED ON THIS COMPLAINT WAS HELD, DOCUMENTED ON FOLIO COMPLETED 14DEC2021.