Catalog Number 368586 |
Device Problem
Device Contamination with Chemical or Other Material (2944)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/26/2022 |
Event Type
malfunction
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Event Description
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It was reported when using the bd vacutainer® bulk gel there was foreign matter in the tube(s) biological and non-biological.The following information was provided by the initial reporter.The customer stated: "the pail of gel is contaminated.".
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Manufacturer Narrative
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Date of event: unknown.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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Manufacturer Narrative
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The following fields were updated due to additional information: d9.Device available for evaluation? yes; d9.Returned to manufacturer on: 05/04/2022.H.6.Investigation summary: catalog number: 368586; batch number: 2017217.Bd received 1 sample and 3 photos for investigation.The photos were reviewed and the customer¿s indicated failure mode for foreign matter was observed.Additionally, the customer samples were evaluated by visual examination and the indicated failure mode for foreign matter with the incident lot was observed.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 foreign matter.Bd was not able to identify a root cause for the indicated failure mode.Complaints received for this device and reported condition will continue to be tracked and trended.Our business team regularly reviews the collected data for identification of emerging trends.H3 other text : see h10.
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Event Description
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It was reported when using the bd vacutainer® bulk gel there was foreign matter in the tube(s) biological and non-biological.The following information was provided by the initial reporter.The customer stated: "the pail of gel is contaminated.".
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Search Alerts/Recalls
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