H10: the device was received for evaluation in an open package.During visual inspection, the hansen port was observed damaged on the side of the data matrix code.The reported condition was verified.There are process controls in place to test the material characteristics of the dialyzer housings, which is called the hansen break test.The procedure applies to all housing parts produced in the injection molding department of the facility.A dialyzer with a missing port would not make it through the manufacturing process to final packaging.The cause of the condition could not be determined; however, the most probable cause would occur during the transportation process.Dialyzer cases that are roughly handled during shipment and travel, as well as cases that are not secured adequately during transport, or are subject to undue force, can potentially become susceptible to breakage and housing damage.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.
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