Catalog Number 362780 |
Device Problems
Short Fill (1575); Volume Accuracy Problem (1675)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 06/15/2020 |
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.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 the bd vacutainer® cpt¿ nh: ~130 iu ficoll¿: 2.0ml had under-fill or low draw of a tube with blood during use.This event occurred 5 times.The following information was provided by the initial reporter: the customer noticed "tubes did not fill correctly.".
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Manufacturer Narrative
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H.6.Investigation: bd had not received samples or photos from the customer for investigation.Therefore, 10 retention samples from bd inventory were evaluated.10 production lot in-house retention samples were draw tested.All tubes were within specification limits.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 non-conformances during manufacturing of the product.H3 other text : see h.10.
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Event Description
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It was reported the bd vacutainer® cpt¿ nh: ~130 iu ficoll¿: 2.0ml had under-fill or low draw of a tube with blood during use.This event occurred 5 times.The following information was provided by the initial reporter: the customer noticed "tubes did not fill correctly.".
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Search Alerts/Recalls
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