Customer reports: the patient had a nasal enteral tube obstruction, and when evaluating and trying to perform mechanical clearance, it was observed that the device is broken in the y connection.Per additional information provided on 03/27/23, the y connector detached & the device was removed & replaced.
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The device history record (dhr) for the reports lots were reviewed, and no abnormal process conditions were present during the manufacturing of the product that could have led to the condition described by the customer.A sample analysis was not possible as there was no photographs or samples provided for evaluation.Without a sample to evaluate, it is not possible to confirm the reported issue, determine a root cause or relate it to a manufacturing process.During the investigation, a review of the manufacturing process was conducted.In general, all process and controls were found properly followed, including sub-assemblies, finished product assembly and packaging.There were no abnormal conditions found that could trigger the reported condition.An improvement opportunity was detected on the product design.A formal corrective/preventative action (capa) was created to address the reported condition and to identify improvement opportunities to the product design.The capa will modify the design and assembly process of the enfit y-port assembly.This design modification will include modifying the current molds for the enfit connector and y-port body to change the device from a winged enfit connector and y-port body design to a no-wing design.
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