Catalog Number 367921 |
Device Problem
Insufficient Information (3190)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 05/15/2017 |
Event Type
malfunction
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Manufacturer Narrative
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Date of event: unknown.The date received by manufacturer has been used for this field.Results: bd had not received samples, but photos were provided by the customer facility for investigation.The photos were evaluated and the customer's indicated failure mode for hemolysis with the incident lot was observed.Additionally, retention samples were selected for evaluation, and the customer's indicated failure mode for hemolysis was not observed.A review of the manufacturing records was completed for the incident lot and no issues were identified.Conclusion: without a sample, an absolute root cause for this incident cannot be determined as bd was not able to duplicate or confirm the customer¿s indicated failure mode.
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Event Description
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It was reported that there was haemolysis with glucose bd vacutainer¿ plastic blood collection tubes - pst plasma separation tube, more than 50%.No serious injury or medical intervention reported.
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Manufacturer Narrative
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Correction: describe event or problem: it was reported that there was haemolysis with bd vacutainer® sodium fluoride potassium oxalate (fx) blood collection tubes, more than 50%.No serious injury or medical intervention reported.Medical device brand name: bd vacutainer® sodium fluoride potassium oxalate (fx) blood collection tubes.
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Event Description
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It was reported that there was haemolysis with bd vacutainer® sodium fluoride potassium oxalate (fx) blood collection tubes, more than 50%.No serious injury or medical intervention reported.
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Search Alerts/Recalls
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