The device history record (dhr) is established based on the serial number sticker on the device package.A serial number was not provided, therefore the dhr could not be reviewed.As part of the manufacturing process, all dhrs are reviewed and approved by quality, prior to release of the product.Samples were already used on patient therefore the device/s could not be taken to the production line for evaluation following custom¿s policy therefore a sample evaluation was not able to be performed.A photograph of the device was provided, and a crack is seen on the y-port.The root cause could not be determined based solely on a photographic evaluation.The manufacturing process of the y-port assembly, tests and inspections were reviewed.They performed leak test following all product specifications.Functional testing and visual inspections are being performed according to the current quality standards and inspection procedures.Although a root cause could not be determined, corrective actions were implemented by installing a new solvent dispenser for a better handling of solvent for the assembly process of the y-port and to improve the structure of the y-port design by eliminating the ¿wing¿ design and replacing it with a ¿no wing¿ design which will increase the surface area of the bond strength for the y-port assembly.
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