N
Patient 1
WITHOUT REVIEWING THE ACTUAL SAMPLE, AN EXACT ROOT CAUSE FOR THE NON-CONFORMANCE REPORTED CANNOT BE DETERMINED AT THIS TIME. A POSSIBLE CAUSE COULD BE BENDING, FRACTURING, BREAKING OF A NEEDLE CAN OCCUR WHEN NEEDLES ARE GRIPPED WITH A NEEDLE HOLDER/FORCEPS AT THE SWAGED AREA AND/OR NEAR THE TIP OF THE DEVICE. THE STRESS AT THE GRIPPED AREA MAY EXCEED THE MAXIMUM STRESS OF THE MATERIAL RESULTING IN BENDING AND/OR FAILURE (BROKEN NEEDLE). THE STRESS ON THE ATTACHMENT SECTION IS GREATLY REDUCED WHEN THE NEEDLE IS HELD IN AN AREA ONE-THIRD (1/3) TO ONE-HALF (1/2) OF THE DISTANCE FROM THE SWAGED END TO THE POINT AS INDICATED IN THE IFU FOR THIS PRODUCT. THE NEEDLE ITSELF IS FROM SUPPLIED BY AN OUTSIDE SUPPLIER. A REVIEW OF THE DEVICE HISTORY RECORDS FOR THE FINISHED GOOD LOT, DID NOT IDENTIFY ANY QUALITY ISSUES DURING THE INCOMING, MANUFACTURING, IN-PROCESS OR FINAL INSPECTION PROCESSES. THERE HAVE BEEN NO LOTS RELEASED FOR DISTRIBUTION WHICH FAILED TO MEET ANY OF THE PRODUCT SPECIFICATIONS OR CURRENT ACCEPTANCE CRITERIA.