The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 21-jul-2023.Investigation summary a device history record review was completed for provided material number 306553 and lot number 3026599.The review did not find any detected non-conformances during the production process that could have contributed to this incident.To aid in the investigation of this issue, two (2) picture samples and three (3) physical samples were returned for evaluation by our quality engineer team.Through inspection of the samples, two (2) syringes were found to be missing the barrel label.The third syringe had two (2) barrel labels applied.This incident most likely resulted from a jam in the plunger rod labeler, which was not cleared.After the jam, the defective syringes were not rejected by the vision system at the plunger rod station.An additional control has been initiated, with the installation of a sensor further downstream to inspect 100% of syringes for barrel label presence.
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