Model Number 367960 |
Device Problem
Obstruction of Flow (2423)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/07/2023 |
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 when using the bd vacutainer® pst¿ gel and lithium heparin blood collection tube there was a clogged/blocked instrumentation probe.This event occurred 62 times.The following information was provided by the initial reporter.The customer stated: the stryrofoam caused an abnormality in the instrument detector.The instrument failure due to foreign material entry into the working zone.".
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Event Description
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It was reported when using the bd vacutainer® pst¿ gel and lithium heparinn blood collection tube there was a clogged/blocked instrumentation probe.This event occurred 62 times.The following information was provided by the initial reporter.The customer stated: the stryrofoam caused an abnormality in the instrument detector.The instrument failure due to foreign material entry into the working zone.".
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Manufacturer Narrative
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Investigation summary: bd had not received samples, but 3 photos were provided for investigation.The photos were reviewed and the indicated failure mode for tray pack residue was observed.The photos do not show the customer's failure mode of clogged instrumentation.No further investigation can be completed on the failure mode of clogged instrumentation as this is not a direct issue with the device.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.This complaint has been confirmed for the indicated failure mode tray pack residue.This complaint has not been confirmed for the indicated failure mode clogged instrumentation.Bd was not able to identify a root cause for the indicated failure mode.
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Search Alerts/Recalls
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