Catalog Number 762165 |
Device Problem
Device Contamination with Chemical or Other Material (2944)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/01/2024 |
Event Type
malfunction
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Manufacturer Narrative
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A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
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Event Description
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It was reported while using the paxgene® blood rna tube there was an indication of contamination in the tube.There were no health consequences or impacts reported.
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Event Description
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It was reported while using the paxgene® blood rna tube there was an indication of contamination in the tube.There were no health consequences or impacts reported.
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Manufacturer Narrative
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The following fields have been updated with additional/corrected information: d.4.Device available for eval: yes.D.4.Returned to manufacturer on: 08-mar-2024.H.6.Investigation summary: bd received two (2) samples for investigation.The samples were evaluated by visual examination and the indicated failure mode for foreign matter (fm) contamination with the incident lot was not observed.Additionally, one hundred (100) retention samples from bd inventory were evaluated by visual examination and no issues were observed relating to fm contamination as all samples met specifications.Based on a review of the device history record for the incident lot, all product specifications and requirements for lot release were met.There were no related quality issues during manufacturing of the product.This complaint is unable to be confirmed for the indicated failure mode of fm contamination.Bd was not able to identify a root cause for the indicated failure mode.Complaints received for this device and reported condition will continue to be tracked and trended.Our business team regularly reviews the collected data for identification of emerging trends.
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Search Alerts/Recalls
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