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 09/19/2018 |
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 the bd vacutainer® glass cpt molecular diagnostics tube had gel separation issues.There was no report of exposure, injury, or medical intervention.
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Manufacturer Narrative
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Investigation summary: 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 manufacturing records was completed for the incident lot and no issues were identified.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.Investigation conclusion: 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.Root cause description: 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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Event Description
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It was reported that the bd vacutainer® glass cpt molecular diagnostics tube had gel separation issues.There was no report of exposure, injury, or medical intervention.
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Search Alerts/Recalls
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