Catalog Number 302104 |
Device Problem
Moisture or Humidity Problem (2986)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 08/16/2018 |
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 a bd¿ syringe, luer slip with needle had water droplets in the barrel.There was no report of exposure, serious injury or medical intervention.
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Manufacturer Narrative
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Six actual samples in sealed package was returned for investigation and subjected visual inspection.No water droplet observed in the barrel.A lot history review was carried out and no related non conformances were raised in association with this packaged lot concluding all inspections were performed per the applicable operations and met qc specifications.Investigation conclusion: based on the visual inspection, the returned samples passed and met visual acceptance criteria.Hence root cause could not be determined on the reported non-conformance.
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Event Description
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It was reported that a bd syringe, luer slip with needle had water droplets in the barrel.There was no report of exposure, serious injury or medical intervention.
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Search Alerts/Recalls
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