Catalog Number 368856 |
Device Problem
Material Protrusion/Extrusion (2979)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/11/2023 |
Event Type
malfunction
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Manufacturer Narrative
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H3.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 that the bd vacutainer® k3e plus blood collection tubes could not be processed due to a molding defect.There was no report of patient impact.
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Manufacturer Narrative
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H.6.Investigation summary: bd had not received samples, but a photo was provided for investigation.The photo was reviewed and the indicated failure mode for damaged tube was observed.Plastic was scraped from the inside of the tube.Additionally, one hundred (100) retention samples from bd inventory were evaluated by visual examination and the issue of damaged tube was not 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 of damaged tube.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.
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Event Description
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It was reported that the bd vacutainer® k3e plus blood collection tubes could not be processed due to a molding defect.There was no report of patient impact.
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Search Alerts/Recalls
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