Catalog Number 364975 |
Device Problem
Device Contamination with Chemical or Other Material (2944)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 10/10/2019 |
Event Type
malfunction
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Manufacturer Narrative
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A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
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Event Description
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It was reported before use the bd vacutainer® urine collection cups had foreign matter in tube; biological and non-biological.The following information was provided by the initial reporter: ¿fm got mixed.¿.
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Manufacturer Narrative
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H.6.Investigation: bd received samples and photos from the customer facility for investigation.The photos were evaluated and the customer¿s indicated failure mode for foreign matter with the incident lot was observed.Additionally, evaluation of the customer samples was performed and foreign matter was observed.A review of the device history record was completed for the incident lot and, based on this review, 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 before use the bd vacutainer® urine collection cups had foreign matter in tube; biological and non-biological.The following information was provided by the initial reporter: ¿fm got mixed.¿.
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Search Alerts/Recalls
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