Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 2105074.Medical device expiration date: 2026-04-30.Device manufacture date: 2021-04-28.Medical device lot #: 2102021.Medical device expiration date: 2026-01-31.Device manufacture date: 2021-02-01.
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H.6.Investigation: photo received for investigation, upon visual inspection of the pictures provided, in one picture it can be observed there is a syringe with the stopper not correctly assembled, additionally the second photo shows foreign matter inside the syringe.This foreign matter noticed is transparent plastic that is blocking the tip of the syringe.The tip of the syringe is not correctly molded and the foreign matter noticed by customer is a consequence of the incorrect molding of the tip.Possible root cause for foreign matter is associated with the molding process.Possible root cause for jammed stopper is related with a misalignment of plunger-stopper-barrel in the assembly station.Dhr from lot 2102021 was reviewed not finding any annotation or deviation regarding the alleged defect.Dhr from lot 2105074 was reviewed and annotation regarding barrel molding was found in dhr.Cavity nº49 of the mold s-27 was cancelled due to a pin that was taken off during manufacturing of this lot.Pins in molds are used to give a carnation geometry to parts.According to the picture received and the annotation found in the dhr, the root cause of the alleged defect is related to the taken off pin with high probability.If a pin is taken off, the inner geometry of the syringe is not correctly manufactured and the tip of the syringe is not molded properly, leaving additional plastic and blocking the tip.
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