Date of event: unknown.The date received by manufacturer has been used for this field.Initial reporter phone number: (b)(6).(b)(4).Investigation summary: level a investigation - complaint evaluation / complaint history check for the event(s) that occurred.Severity: s_2__; occurrence: a complaint history check was performed and this is the 1st related complaint for dimension and needle pain on lot # 9084957.A review of risk management 150rmn-0001-16 revision 13 indicates that the potential risk of this specific reported incident (syringe, dimension, needle pain) was captured and addressed appropriately investigation summary: customer returned photos of 3/10cc syringes.Customer states that 10 units came in a bigger size and it causes more pain.The attached photos were examined and it is difficult to determine the cannula length solely from the attached photos.A review of the device history record was completed for batch# 9084957.All inspections and challenges were performed per the applicable operations qc specifications.There were zero (0) notifications noted that pertained to the complaint.Investigation conclusion: based on the samples and/or photo(s) received the investigation concluded: unconfirmed: bd was not able to duplicate or confirm the customer¿s indicated failure.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.Root cause description: root cause cannot be determined at this time as the issue is unconfirmed.Rationale: based on the investigation, no additional investigation and no capa is required at this time.
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It was reported that 36 syringes 0.3ml 31ga 6mm halfunit 10bagsla had incorrect label information and the wrong cannula size.The following information was provided by the initial reporter: "the needles of the bd syringes of 30 ui (0.3ml) in packages with 10 units are coming in a bigger size.It causes more pain when applying the insulin.We've bought bd ultra fine with the same specifications in the package, but with bigger needles.Additional information received: batch of product 9084957a (confirmed in the pharmacy, because the original package has been discarded); the needles are visually thicker, it has gotten evident while feeling it through the skin, and when compared with another needle; the needles are also neatly longer; there was no harm, but it causes more suffering and too much pain due to the needle's bigger size.".
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