Catalog Number 362753 |
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 08/07/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Date of event: unknown.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 a bd vacutainer® cpt¿ nh: ~130 iu ficoll¿: 2.0ml had gel separation.There was no report of exposure, serious injury or medical intervention.
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Event Description
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It was reported that a bd vacutainer cpt nh: 130 iu ficoll: 2.0ml had gel separation.There was no report of exposure, serious injury or medical intervention.
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Manufacturer Narrative
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Bd received samples and photos from the customer facility for investigation.The photos were evaluated and the customer¿s indicated failure mode for poor barrier separation with the incident lot was observed.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.Bd has initiated further investigation relating to this issue through a capa.The investigation is still on-going and improvements will be made as the potential causes of this issue are identified.Based on evaluation of the customer photos and samples, the customer¿s indicated failure mode for poor barrier separation with the incident lot was observed.Further investigation has been initiated through a capa.The investigation is still on-going and improvements will be made as the potential causes are identified.A capa has been initiated to document further investigation and root cause analysis relating to this issue.The investigation is currently on-going and will be updated as the potential root cause(s) are identified.
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Search Alerts/Recalls
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