(b)(4).The lot was manufactured from january 15, 2015 ¿ january 16, 2015.The device was received for evaluation.Visual inspection revealed a white particle, approximately 1.71 mm in length, floating in the bladder.Fourier transform infrared spectroscopy identified the particle to be acrylic.The cause of the condition was not determined.A capa has been opened to address this issue.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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