BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER® CPT¿ NH: ~130 IU FICOLL¿: 2.0ML; BLOOD SPECIMEN COLLECTION DEVICE
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Catalog Number 362780 |
Device Problem
Incorrect, Inadequate or Imprecise Result or Readings (1535)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 03/17/2020 |
Event Type
malfunction
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Manufacturer Narrative
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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 180 bd vacutainers® cpt¿ nh: ~130 iu ficoll¿: 2.0ml experienced poor separator movement which was noted after use.The following information was provided by the initial reporter: during a new study, the bd cpt tubes did not work as expected.Out of 30 tubes there was no gel movement at 30%, the whole blood was still above the gel after centrifugation.The yield was also lower than expected, 2-5 million leukocytes per tube.Centrifugation conditions were okay, 25min at 1800 rcf and 22°c (temperature controlled centrifuge).In the tubes where no separation had occurred, the supernatant was re-suspended and transferred to a second bd cpt tube.After renewed centrifugation, the separation of the pbmcs had also worked for these samples.The customer is an experienced user, in previous studies she may have had one or two tubes with this phenomenon, but never 30%.
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Event Description
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It was reported that 180 bd vacutainers® cpt¿ nh: ~130 iu ficoll¿: 2.0ml experienced poor separator movement which was noted after use.The following information was provided by the initial reporter: during a new study, the bd cpt tubes did not work as expected.Out of 30 tubes there was no gel movement at 30%, the whole blood was still above the gel after centrifugation.The yield was also lower than expected, 2-5 million leukocytes per tube.Centrifugation conditions were okay, 25min at 1800 rcf and 22°c (temperature controlled centrifuge).In the tubes where no separation had occurred, the supernatant was re-suspended and transferred to a second bd cpt tube.After renewed centrifugation, the separation of the pbmcs had also worked for these samples.The customer is an experienced user, in previous studies she may have had one or two tubes with this phenomenon, but never 30%.
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Manufacturer Narrative
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H.6.Investigation summary: bd had not received samples or photos from the customer facility for evaluation.A review of the device history record was completed for the incident lot and, based on this review, all product specifications and requirements for lot release were met; there were no related quality non-conformances during manufacturing of the product.
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Search Alerts/Recalls
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