While no serious injury resulted in this event, there has been a previous report received where this malfunction resulted in a serious injury.Therefore, this event meets the criteria for reportability per 21 cfr part 803.The actual device was not investigated because this failure is a known issue.A capa was initiated for tip breakage for this batch and investigation showed that the failures for this lot may be related to the supplier's manufacturing process.A scar has been issued to the supplier to further investigate the issue.
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