FILTER RETENTION PLATE

Additional Manufacturer Narrative

EXEMPTION NUMBER: E2014018. MANUFACTURING SITE EVALUATION: PO RESIDUE FOUND AFTER STERILIZATION ON PRODUCT JK100 AND MD344. JK100: THE DEVICE ARRIVED IN A CLEAN STATUS WITHOUT VISIBLE DAMAGE. DURING THE INVESTIGATION A LOOSENED FILTER RETENTION PLATE JK100 AND ROUND FILTER POLYPROPYLENE MD344. ADDITIONALLY, WE FOUND VISIBLE DAMAGES AND SCRATCHES. A VISUAL INSPECTION OF THE FILTER RETENTION PLATE. WE FOUND NO VISUAL FAILURE. ADDITIONALLY, WE MADE A FUNCTIONAL TEST ACCORDING TO THE STERILE CONTAINER FUNCTIONAL TEST. CHECKING THE FILTER HOLDER, WE FOUND THAT THE FILTER HOLDER DO NOT HAVE A FULL SURFACE CONTACT AT THE EDGE. NEXT A VISUAL INSPECTION WAS PERFORMED OF THE ROUND FILTER POLYPROPYLENE MD344. WE FOUND VISIBLE DAMAGES AND A CUT. JK100: THE PRODUCTS DOES NOT REQUIRE BATCH MANAGEMENT; A REVIEW OF THE DEVICE QUALITY AND MANUFACTURING HISTORY RECORDS IS NOT POSSIBLE. MD344: A REVIEW OF THE DEVICE QUALITY AND MANUFACTURING HISTORY RECORDS IS NOT POSSIBLE BECAUSE THE BATCH NUMBER IS UNKNOWN. CONCLUSION: THE ROOT CAUSE OF THE PROBLEM IS MOST PROBABLY USAGE AND DESIGN RELATED.

Description of Event or Problem

IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL TO THE COMPANY SALES REPRESENTATIVE "THERE IS AN INCREASING AMOUNT OF SETS WITH RESIDUE FOUND INSIDE CONTAINER AFTER STERILIZATION". AFTER SWIPING THE BOTTOM OF THE CONTAINER THE OR STAFF (IN SOME CASES) ARE FINDING A DARK RESIDUE ON GLOVE. NO PATIENT INJURY. NO DELAY IN SURGERY. COMPONENTS IN USE LISTED AS CONCOMITANT DEVICES ARE: FILTER RETENTION PLATE / JK100, ROUND FILTER POLYPROPYLENE / MD344.