Correction: describe event or problem: it was reported with the use of the bd plastipak¿ syringe there was an issue with package damaged and open from one side full of black dirt.There were two occurrences of this incident reported within the month.Discovered before use.Investigation summary: two samples belonging to lot number 1809272 were received for evaluation by our quality engineer.Through visual inspection of the samples, the packages were observed open on one side due to an extra piece of foreign paper within the seal.A device history record review did not reveal any documented quality issues during the production of lot number 1809272 that could have contributed to this incident.Investigation conclusion: during the primary packaging process, film and paper are guided along a chain in the packaging machine.Once the blister packaging is sealed, longitudinal and transversal cutters cut the extra pieces of film and paper and they are rejected to scrap by a vacuum system.A failure in the vacuum system resulted in improper rejection of the extra paper and film pieces, which caused them to be sealed within the following blister packages.The black foreign matter is grease from the manufacturing chain where the film and paper are guided.Rationale: manufacturing personnel have been made aware of this incident.Based on the preventive measures in place and the current inspection plan, we believe this is an isolated incident with an unlikely reoccurrence.Complaints received for this device and defect will be monitored by our quality team for signs of emerging trends.
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