This mdr was generated under protocol b10009704 as a result of warning letter cms# (b)(4).A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.A product sample was received for evaluation.Visual and functional testing were performed.Visual inspection the tip of the hypodermic needle was damaged (burred), thus confirming the complaint.During inspection of stock, in which samples from four different raw material lots were inspected; no issues or damage were observed with the samples from stock.While the damage to the returned used sample was observed, the root cause of the issue could not be determined.This issue will be monitored for any increase in occurrence.If the occurrence of this issue increases significantly, additional investigative action will be taken.(udi) and (510k) are unknown.No information available to date.
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