H.6.Investigation: one photo and one sample were received by our quality team for evaluation.From the photo, the syringe barrel tip was observed to be broken.On the returned sample, the syringe barrel tip was observed to be broken, and missing a broken tip piece.A device history record could not be evaluated as the lot number is unknown.After evaluation on the sample, the team found that there was a rupture at the tip of the barrel.The sample could have been hit by heavy force and resulted in breaking.The needle assembly station and primary and secondary packaging were reviewed.At the needle assembly station, there are no possible contact points to the needle that can cause damage to the syringe tip.At the primary and secondary packaging, no activities were observed that could contact the point on the syringe tip or needle.As no batch number was known and no abnormalities on the machine history records during production were able to be detected, the root cause could not be determined.H3 other text : see h.10.
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