Submit date: 2/23/2018.The incident sample has been requested but to date has not been received for evaluation.If the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.If information is provided in the future, a supplemental report will be issued.
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A review of the device history record (dhr) for lot 703785 indicates that there were no defects detected in 544 visual samples inspected from the lot.There were no non-conformance reports (ncr)¿s issued to the lot.There were no samples submitted with this complaint for lot # 703785.The reported condition could not be confirmed without an actual sample to evaluate.The exact root cause could not be determined based on the available information.The customer returned sample from a different lot number for the same reported condition and the defect of string flash was identified and confirmed.The most likely root cause was due to flash, which is stringy plastic material attached at the molded part's gate (the entrance to the mold cavity) forming when melted plastic resin remains at the injection gate as the two mold halves separate.Prior to a lot¿s release, the lot must be deemed acceptable by passing inspections that are based on a valid sampling plan.Inspectors routinely examine a statistical sample both physically and visually.Specifically, samples are inspected for foreign matter and molding flash.The lot met the acceptance criteria and was released.An issue impact assessment (as known as a health hazard evaluation or health hazard assessment) was conducted for magellan gate.The assessm ent discusses a potential hazard scenario where the plastic fibers are injected into a patient and assesses the risks associates with such an event.The likelihood of occurrence was considered ¿rare¿, the probability of injury occurring was considered ¿unlikely but possible¿, and the severity of the injury was considered ¿severe¿.The overall risk score was ¿low¿ for that assessment.Based on the low risk associated with the issue, no corrective action will be taken at this time.If information is provided in the future, a supplemental report will be issued.
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