Model Number 368650 |
Device Problem
Difficult or Delayed Activation (2577)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 12/10/2019 |
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 that the bd vacutainer® eclipse¿ blood collection needle with pre-attached holder safety shield fell off after use.This occurred on 2 separate occasions in the same day.The following information was provided by the initial reporter: "customer called in to report that the safety shield fell off.Occurred 2 times today, occurred after the needle was used, no needle stick.".
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Event Description
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It was reported that the bd vacutainer® eclipse¿ blood collection needle with pre-attached holder safety shield fell off after use.This occurred on 2 separate occasions in the same day.The following information was provided by the initial reporter: "customer called in to report that the safety shield fell off.Occurred 2 times today, occurred after the needle was used, no needle stick.".
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Manufacturer Narrative
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H.6.Investigation summary: bd received samples from the customer facility for investigation.The samples were evaluated and the customer's indicated failure mode for safety shield separates during use with the incident lot was not observed.Testing of the customer samples was performed and safety shield separates during use was not 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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Search Alerts/Recalls
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