Medical device expiration date: unknown.Device manufacture date: unknown.Investigation summary: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.Complaints received for this device and reported condition will continue to be tracked and trended.If samples are received in the future the complaint will be reopened for further investigation.Due to the batch being unknown, no dhr review can be completed.As no samples and/or photo(s) were received the investigation concluded: unconfirmed: bd was not able to duplicate or confirm the customers indicated failure as no samples or photos were returned root cause cannot be determined at this time as the issue is unconfirmed as no samples or photos were returned.Based on the above, no additional investigation and no corrective/preventative action (capa) or situational analysis (sa) is required at this time.
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It was reported that a sticky, foreign liquid came out of the tip of the bd ultra-fine" ii insulin syringe needle.The following information was provided by the initial reporter, translated from (b)(6) to english: "a sticky liquid came out from the needle tip of an unused product.".
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