H10: manufacturing review: the device history record review was performed for the affected lot number of the mick cartridge.No issues were noted.Investigation summary: the mick cartridge with 6 seeds was returned together with the mick applicator.The mick cartridge was jammed in the applicator and the seeds were not able to be discharged.With the help of pliers, moderate force , pulling and rotating the cartridge was separated from the applicator.There were 6 seeds inside the mick cartridge among one bent seed.The investigation is confirmed for reported issue, and the root cause is undetermined.Labeling review: labeling was reviewed and found to be adequate.There is a caution statements, which state: "do not overtighten the round magazine head", "do not let seeds drop into the magazine groove" and "do not use force on seeds; handle seeds gently" h11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.H3 other text : see h10.
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