Qn# (b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.The ifu provided with the kit informs the user, "the practitioner must be aware of potential air embolism associated with leaving open needles, sheaths, or catheters in venous puncture sites or as a consequence of inadvertent disconnects.To lessen the risk of disconnects, only securely tightened luer-lock connections should be used with this device.Follow hospital protocol for all sheath and side port maintenance".The ifu also states, "do not suture directly to the outside diameter of access device to minimize the risk of cutting or damaging device or impeding device flow".A device history record review was performed based on a potential lot from sales history, and no relevant findings were identified.Without the device to evaluate, the complaint could not be confirmed, and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.
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