Event came to the knowledge of siemens healthineers on (b)(6) 2022 from healgen who learnt through fda medwatch program email on (b)(6) 2022.Customer did not contact siemens or the manufacturer - healgen.The customer failed to follow the instructions provided with the device.Quick reference instructions also mentions to make sure there is a tight fit of filter tip to the tube.This would have avoided filter tip to pop out.For any questions or concerns, customer care hotline phone number and email are provided on quick reference instructions provided with each test kit.Per the safety data sheet, "not classified as dangerous according to directive (ec) no.(b)(6) 2008.".Although the buffer solution is not intended to come in contact with the patient or user, however, spewing will not result in any adverse event.The cause of this event is unknown.
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As holders of the emergency use authorization, siemens healthcare diagnostics is submitting this report on behalf of the manufacturer healgen scientific.The customer reported that upon squeezing the sample tube to apply sample to clinitest covid test strip, filter pops off the tube due to clogged filter, spewing out sample with reagent.There was no reported injury due to this event.
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