The lot was manufactured january (b)(4).The device was received for evaluation containing fluid in the bladder.Visual inspection was performed and evidence of leak/backflow was observed at the fillport when the fillport cap was removed.Further inspection revealed the cause of the leak/backflow condition due to a particle lodged under the device checkband.A fourier transform infrared spectroscopy test identified the particle as acrylic material, part of the stressmember.The reported condition was verified.The cause of the particle was not determined.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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