BECTON, DICKINSON AND COMPANY (BD) BD VACUTAINER® LH PST¿ II PLUS BLOOD COLLECTION TUBES; BLOOD SPECIMEN COLLECTION DEVICE
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Catalog Number 367376 |
Device Problem
Fungus in Device Environment (2316)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/30/2021 |
Event Type
malfunction
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Event Description
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It was reported when using the bd vacutainer® lh pst¿ ii plus blood collection tube there was a presence of mold.This event affected 2 devices.The following information was provided by the initial reporter.The customer stated: there was a "moldy lid.".
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Manufacturer Narrative
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Investigation summary: bd had not received samples, but 1 photo was provided for investigation.The photo was reviewed and the indicated failure mode for foreign matter was observed.Black dots can be seen embedded in one of the hemogard caps.Embedded foreign matter is, by its nature, isolated from any specimen, therefore it is a cosmetic defect.Additionally, 100 retention samples from bd inventory were evaluated by visual examination and the issue of foreign matter 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 foreign matter.Bd was not able to identify a root cause for the indicated failure mode.
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Manufacturer Narrative
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Investigation summary: bd had not received samples, but 1 photo was provided for investigation.The photo was reviewed and the indicated failure mode for foreign matter was observed.Black dots can be seen embedded in one of the hemogard caps.Embedded foreign matter is, by its nature, isolated from any specimen, therefore it is a cosmetic defect.Additionally, 100 retention samples from bd inventory were evaluated by visual examination and the issue of foreign matter 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 foreign matter.Bd was not able to identify a root cause for the indicated failure mode.
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Event Description
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It was reported when using the bd vacutainer® lh pst¿ ii plus blood collection tube there was a presence of mold.This event affected 2 devices.The following information was provided by the initial reporter.The customer stated: there was a "moldy lid.".
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Search Alerts/Recalls
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