Exemption number e2019001-permits numbering sequence to begin with 10000, to avoid duplication of report numbers due to process transition.There may be gaps in numbering for reports submitted during the transition period.Visual inspection was performed on the returned device.The reported kink was not confirmed; however, it is likely that the reported kink was located at the separated location noted during return analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other similar incidents and/or complaints from this lot.The investigation was unable to determine a conclusive cause for the reported kink.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of this device.
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