Catalog Number 367962 |
Device Problem
Device Ingredient or Reagent Problem (2910)
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Patient Problem
Hemolysis (1886)
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Event Date 04/25/2022 |
Event Type
malfunction
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Event Description
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It was reported when using the bd vacutainer® pst¿ gel and lithium heparinn (lh) blood collection tubes device experienced hemolysis.The following information was provided by the initial reporter.The customer stated: it was reported that during literature search it was reported that there was higher rates of hemolytic samples collected using bd vacutainer compared to s-monovette in aspiration mode.
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Manufacturer Narrative
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Date of event: unknown.Medical device expiration date: unknown.Initial reporter state: address information was not able to be obtained, therefore, (b)(6) was used as a place holder.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
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Manufacturer Narrative
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H.6.Investigation: bd had not received samples or photos for evaluation.Additionally, bd was unable to determine the specific lot number associated with this complaint; therefore, a review of the device history record could not be conducted.This complaint could not be confirmed and the root cause is undetermined.
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Event Description
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It was reported when using the bd vacutainer® pst¿ gel and lithium heparinn (lh) blood collection tubes device experienced hemolysis.The following information was provided by the initial reporter.The customer stated: it was reported that during literature search it was reported that there was higher rates of hemolytic samples collected using bd vacutainer compared to s-monovette in aspiration mode.
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Search Alerts/Recalls
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