Manufacturing, packaging or shipping problem

Definition

Problem associated with any deviations from the documented specifications of the device that relate to nonconformity during manufacture to the design of an item or to specified manufacturing, packaging or shipping processes (out of box problem).

7 subordinate codes

• XE5Y1Product quality problem
• XE1K1Defective component
• XE9CDDefective device
• XE12LDevice damaged prior to use
• XE8RYPackaging problem
• XE151Device misassembled during manufacturing or shipping
• XE8ZAShipping damage or problem

Also indexed as

Nearby in Aspects of incidents related to devices

• XE4HKPatient device interaction problem
• XE52XChemical problem
• XE4LPMaterial integrity problem
• XE2GFMechanical problem
• XE941Optical problem
• XE28YOutput problem
• XE16CElectrical or electronic property problem
• XE55UCalibration problem