Catalog Number 362780 |
Device Problem
Break (1069)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/29/2021 |
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.(b)(4).
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Event Description
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It was reported when using the bd vacutainer® cpt¿ nh: ~130 iu ficoll¿: 2.0ml there was glass breakage during use.This event occurred 2 times.The following information was provided by the initial reporter: translated to english.The customer stated: the "cpt tube has been breaking in the centrifuge on two different occasions.The samples come from patients with infectious diseases.To avoid any risk for spreading, they have ordered new buckets to the centrifuges.".
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Event Description
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It was reported when using the bd vacutainer® cpt¿ nh: ~130 iu ficoll¿: 2.0ml there was glass breakage during use.This event occurred 2 times.The following information was provided by the initial reporter: translated to english.The customer stated: the "cpt tube has been brekaing in the centrifuge on two different occasions.The samples come from patients with infectious diseases.To avoid any risk for spreading, they have ordered new buckets to the centrifuges.".
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Manufacturer Narrative
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H.6.Investigation: bd had not received samples or photos for investigation.Therefore, retention samples from bd inventory were evaluated by visual examination and no issues were observed relating to defective product as all samples met specifications.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.Bd was not able to identify a root cause for the indicated failure mode.H3 other text : see h.10.
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Search Alerts/Recalls
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