Foreign report source: (b)(4).Device evaluation: one epifuse connector was returned to smiths medical for investigation.Upon immediate visual inspection of the connector, it was confirmed that the hinge was damaged.Per the kit manufacturing process, a 100% inspection is performed on the appearance of epifuse connectors before installation.Therefore, it was noted that the hinge part likely was cracked and damaged when using the epifuse connector, but could not be confirmed.The hinge damage confirms the reported complaint allegation.The evaluation noted the problem source of the event as the supplier.
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