Qn#(b)(4).The actual device was not returned; however, the customer provided two photos for analysis.The complaint of an extension line/juncture hub separation was able to be confirmed by the photos.The photos revealed the distal extension line had completely separated from the juncture hub.The distal extension line was not pictured.A complete visual inspection could not be performed as no sample was returned for analysis.A device history record review was performed, and no relevant findings were identified.The instructions for use (ifu) provided with this kit warns the user, "do not apply excessive force in placing or removing catheter or guidewire.Excessive force can cause component damage or breakage.If damage is suspected or withdrawal cannot be easily accomplished, radiographic visualization should be obtained and further consultation requested." based on the customer description and the returned photos, user error - unintentional patient damage caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.
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