The date received by manufacturer has been used for this field.(b)(6).Results: one loose sample was returned for evaluation.A visual/microscopic inspection revealed no needle through the shield.However, holes in the shield, possibly created by the cannula, were visualized.The sample also exhibited a bent cannula.Conclusion: although the returned sample showed holes in the needle shield and a bent cannula, an absolute root cause for this incident cannot be determined.The sample has been forwarded to the manufacturing site in (b)(4) for further evaluation.Upon completion of the investigation, a supplemental mdr will be submitted.(b)(4).
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Results: (b)(4) received (1) loose shielded 1cc syringe.The returned syringe was examined and no needle through the shield was observed.However, holes in the shield, possibly created by the cannula, were observed in the shield.Also, the sample exhibited a bent cannula.This indicates that the cannula was through the shield and exposing the cannula, which could cause a needle stick.The dhr for batch #5159705 was reviewed and there were zero (0) quality notifications written for issues related to needle thru shield.Conclusion: an absolute root cause for this incident cannot be determined.However, our quality engineer notes that a probable root cause for this incident is the needle was likely bent prior to the shielding operation.The angularity camera likely identified the bent needle, however when the ejector fired the part either got stuck in the dial or the ejector was out of time.During manufacturing, a visual in-process inspection of twenty four (24) parts is performed every two hours for bent needle and needle penetrating shield.This defect would be rejected if found during inspection and processed per quality notification process.The eject station is challenged at start up and every four hours.If the system fails to eject known defects, the process is to reject back to the last good visual inspection and process per quality notification process.
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