Catalog Number 366408 |
Device Problem
Leak/Splash (1354)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 05/06/2020 |
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 stoppers are not staying on tube during use with a bd vacutainer® no additive (z) plus tubes.The following information was provided by the initial reporter: it was reported that you are having problems with the lids staying on after the original vacuum was broken.
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Event Description
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It was reported that stoppers are not staying on tube during use with a bd vacutainer® no additive (z) plus tubes.The following information was provided by the initial reporter: it was reported that you are having problems with the lids staying on after the original vacuum was broken.
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Manufacturer Narrative
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H.6.Investigation: bd received samples from the customer facility for investigation.The samples were evaluated and the customer's indicated failure mode for stopper function with the incident lot was observed.Testing of the customer samples was performed and stopper function 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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Search Alerts/Recalls
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