Catalog Number 362780 |
Device Problem
Incorrect, Inadequate or Imprecise Result or Readings (1535)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/11/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Initial reporter phone#: (b)(6).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 thebd vacutainer® cpt¿ mononuclear cell preparation tube there was poor separator movement.This event occurred 10 times.The following information was provided by the initial reporter.The customer stated: "the tubes are not work correctly.After spinning, the different blood fractions are not appropriately separated.All the blood stayed above the polyester gel.".
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Event Description
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It was reported when using thebd vacutainer® cpt¿ mononuclear cell preparation tube there was poor separator movement.This event occurred 10 times.The following information was provided by the initial reporter.The customer stated: "the tubes are not work correctly.After spinning, the different blood fractions are not appropriately separated.All the blood stayed above the polyester gel.".
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Manufacturer Narrative
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The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 2021-11-12.H6: investigation summary: bd received 4 samples and 1 photo for investigation.The photo was reviewed and the indicated failure mode for sample quality was not observed.The photo was evaluated and shows the case of the product and does not show the failure mode.Additionally, the customer samples were evaluated along with retention samples of the incident lot selected from bd inventory.The samples were tested and upon completion, the indicated failure mode for sample quality was observed.No difficulties were encountered during blood collection and all tubes appeared to exhibit proper fill.Bd was able to confirm the customer¿s indicated failure (poor separation) because the defect was evident in two of the four returned lot samples and in one of the control lot samples.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 sample quality.Bd was not able to identify a root cause for the indicated failure mode.H3 other text : see h10.
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Search Alerts/Recalls
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