Catalog Number 365327 |
Device Problems
Fluid/Blood Leak (1250); Incorrect, Inadequate or Imprecise Result or Readings (1535)
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Patient Problem
Exposure to Body Fluids (1745)
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Event Date 11/25/2021 |
Event Type
malfunction
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Manufacturer Narrative
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A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
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Event Description
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It was reported that bd vacutainer® sst¿ ii advance plus blood collection tubes was missing additive and was a cracked tube.The following information was provided by the initial reporter: " a layer of clotted blood was observed after centrifugation".
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Event Description
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It was reported that bd vacutainer® sst¿ ii advance plus blood collection tubes was missing additive and was a cracked tube.The following information was provided by the initial reporter: " a layer of clotted blood was observed after centrifugation".
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Manufacturer Narrative
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Investigation summary: bd had not received samples or photos for investigation.Therefore, four (4) retention samples from bd inventory were evaluated by functional testing and no issues were observed relating to leaking tubes 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.This complaint is unable to be confirmed for the indicated failure mode of leaking tubes.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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