Catalog Number 762165 |
Device Problem
Leak/Splash (1354)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 06/08/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.Device manufacture date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).
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Event Description
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It was reported during use the paxgene® blood rna tube the tube cracked.The following information was provided by the initial reporter: the customer noticed the tube cracked when removing the tube from the freezer."the tube was used a few years ago and the customer states they have not had an issue with tubes cracking during centrifugation.".
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Event Description
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It was reported during use the paxgene® blood rna tube the tube cracked.The following information was provided by the initial reporter: the customer noticed the tube cracked when removing the tube from the freezer."the tube was used a few years ago and the customer states they have not had an issue with tubes cracking during centrifugation.".
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Manufacturer Narrative
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H.6.Investigation summary: bd had not received samples or photos from the customer facility for evaluation.Additionally, bd was unable to determine the specific lot number associated with this complaint.Therefore, a review of the device history record could not be conducted.
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Search Alerts/Recalls
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