Catalog Number 309646 |
Device Problem
Manufacturing, Packaging or Shipping Problem (2975)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 12/19/2018 |
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 with the use of the bd luer-lok¿ syringe sterile, single use there was an issue with brown substance on syringe.
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Manufacturer Narrative
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Investigation summary: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident, therefore a root cause could not be determined.Furthermore, a device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.
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Event Description
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It was reported with the use of the bd luer-lok¿ syringe sterile, single use there was an issue with brown substance on syringe.
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Search Alerts/Recalls
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