BECTON, DICKINSON & CO. 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 Consequences Or Impact To Patient (2199)
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Event Date 07/05/2018 |
Event Type
malfunction
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Manufacturer Narrative
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(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 that a bd vacutainer® cpt¿ nh: ~130 iu ficoll¿: 2.0ml produced erroneous results.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 produced erroneous results.There was no report of exposure, serious injury or medical intervention.
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Manufacturer Narrative
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Due to an it issue beginning on (b)(6) 2018, previously filed emdrs did not contain required fields.This supplemental emdr is filed to provide the following omitted fields: event attributed to: other; device single use?: no; device returned to manufacture: no.Bd had not received samples, but photos were provided by 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, 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.Based on an assessment of severity and frequency, it was determined that a capa is required at this time in order to determine the root cause associated with this issue and implement corrective actions.The investigation is currently on-going and further improvements will be made as the potential root cause(s) are identified.
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Search Alerts/Recalls
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