Investigation: two samples were received for evaluation.They are in a disposable plastic glove.They are with no packaging flow wrap.Both have the plunger rod- rubber stopper, the tip cap and saline solution.The barrel label confirms the lot#7173520.Both syringes have a barrel crack towards the bottom part.One has ¾¿ length and the other crack has 1 3/8 ¿length.Failure mode is verified.Possible root cause for the barrel crack could be the diverter right before the packaging flow wrapper, or that the packaged product experienced excessive compression force.At this time, we have no evidence for any of these two possible root causes as all our inspections performed while manufacturing this batch were accepted; no rejections were documented.A device history review was completed with the following results: there were no issues documented during the production of this batch for barrel/flange damage.Dhr/bhr review: there were no issues documented during the production of this batch for barrel/flange damage.Investigation comments: all our inspections performed while manufacturing this batch were accepted; no rejections were documented.Update 4/06/2018.Two samples were received.They are in a disposable plastic glove.They are with no packaging flow wrap.Both have the plunger rod- rubber stopper, the tip cap and saline solution; the barrel label confirms the lot#7173520.Both syringes have a barrel crack towards the bottom part.One has ¾¿ length, and the other crack has 1 3/8 ¿length.Product within specification? yes; no.Root cause could not be determined.There were no qns issued during the production of this batch listed in the complaint.All inspections were accepted during the production of this batch.There was no issue documented about barrel/flange damaged.Capa not required for this event.
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