Root cause: the true root cause cannot be determined at this time due to the lack of a sample for evaluation.Potential root causes have been identified but are not limited to the following: an end use error or an event isolated to a single reporting customer.The product's instructions for use includes a warning that "care should be exercised whenever handling sharp needles to prevent accidental needle sticks." corrective action: due to the investigation and root cause determination, a corrective action has not been identified as being necessary.Investigation summary: an internal complaint ((b)(4)) was received indicating the needle of an umbilicup (part 72-8000ns, lot unknown) pricked a healthcare provider.The sample was not returned for evaluation because the product was discarded by the end user due to contamination.Additionally, a lot number was not provided by the end user.Therefore, the complaint investigator was unable to review the work order for discrepancies that may have contributed to the reported event.Deroyal has sold (b)(4) cases of the finished good from october 4, 2017 to september 5, 2018.Each case contains (b)(4) eaches, which equates to (b)(4) eaches sold.A review of complaints for the same time period yielded no similar issues reported.This results in a complaint-to-sales ratio of (b)(4) percent.Deroyal will continue to monitor post-market feedback and will recognize in the future if this issue reoccurs.Preventive action: due to the investigation and root cause determination, a preventive action has not been taken.The investigation is complete at this time.If new and critical information becomes available, this report will be updated.
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