Model Number 367986 |
Device Problem
Fungus in Device Environment (2316)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 01/23/2020 |
Event Type
malfunction
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Manufacturer Narrative
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A sample is available for evaluation.Upon completion of the investigation, a supplemental report will be filed.
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Event Description
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It was reported that there was possibly a fungus inside the gel with a bd vacutainer® sst¿ blood collection tubes.The following information was provided by the initial reporter, translated from spanish to english: it was detected in a 367986 tube a particle inside the gel, possibly a fungus.
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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.
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Event Description
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It was reported that there was possibly a fungus inside the gel with a bd vacutainer® sst¿ blood collection tubes.The following information was provided by the initial reporter, translated from spanish to english: it was detected in a 367986 tube a particle inside the gel, possibly a fungus.
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Search Alerts/Recalls
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