Catalog Number 368837 |
Device Problem
Leak/Splash (1354)
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Patient Problem
Blood Loss (2597)
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Event Date 01/06/2020 |
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¿ signal¿ blood collection needle's rubber sleeve got stuck on the non-patient end.As a result, blood leaked past the needle when removing the tube during use.This occurred on 10 separate occasions, but the dates and/or patient information are unknown.The following information was provided by the initial reporter, translated from (b)(6) to english: "rubber sticks to the non-patient side which causes the blood to run out of the needle after removing the tube.".
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Manufacturer Narrative
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H.6.Investigation summary : bd had not received samples or photos from the customer facility for evaluation.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 section h.10.
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Event Description
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It was reported that the bd vacutainer® eclipse¿ signal¿ blood collection needle's rubber sleeve got stuck on the non-patient end.As a result, blood leaked past the needle when removing the tube during use.This occurred on 10 separate occasions, but the dates and/or patient information are unknown.The following information was provided by the initial reporter, translated from dutch to english: "rubber sticks to the non-patient side which causes the blood to run out of the needle after removing the tube.".
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Search Alerts/Recalls
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