Catalog Number 367864 |
Device Problem
Device Contamination with Chemical or Other Material (2944)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/09/2021 |
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.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).
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Event Description
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It was reported that prior to use with bd vacutainer® k2e 10.8mg plus blood collection tubes foreign matter "glass" was discovered in tube.Pcn 367864, lot 0149372: defect is piece of broken plastic fm inside the tube.
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Event Description
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It was reported that prior to use with bd vacutainer® k2e 10.8mg plus blood collection tubes foreign matter "glass" was discovered in tube.The following information was provided by the initial reporter: pcn 367864 lot 0149372 defect is piece of broken plastic fm inside the tube.
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Manufacturer Narrative
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The following fields were updated due to additional information: d.10.Device available for eval?: yes.D.10.Returned to manufacturer on: 2/1/2021.H.6.Investigation: bd received 1 samples for investigation.The samples were evaluated by visual examination and the indicated failure mode for foreign matter with the incident lot was observed.Bd determined that the most likely root cause of the fm is that the fragment of plastic tube entered the complaint tube whilst both were in the large super-sack used to store/transport tubes around the site.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.
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Search Alerts/Recalls
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