Catalog Number 365000 |
Device Problem
Leak/Splash (1354)
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Patient Problem
No Patient Involvement (2645)
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Event Date 01/18/2021 |
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.(b)(4).
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Event Description
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It was reported that prior to use with 5 bd vacutainer® z (no additive) urine tube - conical the tubes were discovered to be cracked.The following information was provided by the initial reporter, translated from (b)(6) to english: the customer reported about something like scratch found on tubes.
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Event Description
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It was reported that prior to use with 5 bd vacutainer® z (no additive) urine tube - conical the tubes were discovered to be cracked.The following information was provided by the initial reporter, translated from japanese to english: the customer reported about something like scratch found on tubes.
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Manufacturer Narrative
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Investigation: bd had not received samples or photos for evaluation.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 issues during manufacturing of the product.Bd was not able to identify a root cause for the indicated failure mode.H3 other text : see h.10.
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Search Alerts/Recalls
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