Health Canada — Medical Devices · Canada · 2016-12-13 · Type III
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Reported risk: The medicine cups have gradation markings on the side in millilitres. The increments are 2.5, 5, 7.5, 10, 12.5, 15, 20, 25, 30 mL. Some cups repeat the 5 mL mark at the 10 mL location so that the increments appear as: 2.5, 5, 7.5, 5, 12.5, 15, 20, 25, 30 mL. Therefore a certain number of cups in each case of product will have incorrect markings. The cups are injection molded on a machine that has 64 cavities (a cavity is a mold for a cup). Therefore 64 cups can be produced at once with each injection of material. Each cavity is numbered and the number is embossed on the bottom of the cup. Cavity #44 is the defective mold with the incorrect increments. Therefore every cup numbered #44 on the bottom will have the defect. The cups are packaged in sleeves of 100 stacked cups and packaged 500 stacks in a case (5,000 cups). There will be 2, 4, or 6 sleeves containing cups from cavity #44 in a case, which comes out to 50-150 cups per case. This is based on how the robot stacks, combines, and bags the product. Therefore there is the potential for 150 defective cups in a case.
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