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Patient 1
THE RETURNED BAG WAS VISUALLY INSPECTED; A TEAR IN THE FILM, APPROXIMATELY 1/8-INCH IN LENGTH, WAS OBSERVED IN THE JUNCTION AREA OF TWO BAG WELDS. THE FILM EDGES OF THE TEAR HAD A STRETCH APPEARANCE AS IF THE FILM HAD BEEN PULLED APART. THE FAILURE MODE WAS UNIQUE FROM PREVIOUS LEAK REPORTS INVOLVING THIS PRODUCT STYLE IN SEVERAL WAYS: PREVIOUS COMPLAINTS HAVE BEEN ATTRIBUTED TO USER HANDLING TECHNIQUE ISSUES AFTER THE BAGS WERE FROZEN. THIS ONE OCCURRED DURING THE FILLING PROCESS. FAILURE MODES FROM PREVIOUS REPORTS PRESENTED THEMSELVES AS SMALL PIN HOLES OR FILM CRACKS. THE EXACT ROOT CAUSE WAS UNDETERMINED. HOWEVER, A REVIEW OF THE BAG PRODUCTION PROCESS INDICATED A SINGLE MANUAL PROCESS STEP WHERE AN ISSUE OF THIS NATURE COULD POSSIBLY OCCUR. THE BAG IS PRODUCED WITH 2 SEPARATE LAYERS OF FILM, WHICH ARE MANUALLY PLACED ON TOOLING AND WELDED. IF ONE OF THE FILM LAYERS IS NOT MANUALLY PLACED IN A FLAT ORIENTATION, THERE IS A POSSIBILITY THE WELD TOOLING COULD PINCH THE FILM NEAR THE PORT WELD JUNCTION AND RESULT IN A TEAR OR HOLE. THIS IS THE LOCATION WHERE THE BAG TEAR WAS OBSERVED ON THE RETURNED SAMPLE. SINCE THERE HAVE BEEN NO KNOWN PREVIOUS REPORTS OF THIS NATURE THIS ISSUE APPEARS TO BE AN ISOLATED OCCURRENCE.