Investigation summary: on 24jan2018, holdrege received thirty-seven (37) 0.5ml, 12.7mm, 28g syringes sealed in blisterpaks with shelf carton from batch# 7024847.All samples were decontaminated per hstr-17 prior to being evaluated.Upon evaluation by qe ah on 06 feb 2018, all returned samples were cycle tested and there were no indications or notations of increased force required to complete the test.All samples were additionally visualized in their assembled configuration and all stoppers and plunger rods were found to be unremarkable.As there were no samples exhibiting the customer's described defect, bd is unable to confirm the reported defect condition at this time.Root cause cannot be determined at this time as the issue is unconfirmed.A review of the device history record was completed for batch# 7024847.All inspections and challenges were performed per the applicable operations qc specifications.There was one (1) notification [200690135] noted that did not pertain to the complaint.Based on the investigation, no additional investigation and no capa is required at this time.
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