Lot number: requested, unknown.Expiration date: unknown due to unknown lot number.Implanted date: device was not implanted.Occupation: master of science in nursing, registered nurse (msn, rn).Device manufacture date: unknown due to unknown lot number.Since the actual sample was not returned to ashitaka factory, the investigation of it was unable to be performed.Review of the manufacturing record and the shipping inspection record could not be performed since the involved lot number was unknown.Ifu of this product includes the following warning."before starting infusion, verify that the catheter has not been kinked or blocked.Failure to abide by this warning may cause the catheter to break/rupture/separate, resulting in damage to the vessel." regarding this case, it was inferred that the actual product was ruptured due to excessive pressure applied for some reason.However, since the actual product could not be investigated, and the record inspections could not be performed due to the unknown lot number, the cause of occurrence could not be identified.(b)(4).
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