(b)(4).The customer report of a blocked catheter could not be confirmed by visual inspection of the customer supplied photo.A full complaint verification testing could not be performed as no sample was returned for analysis.The instructions for use (ifu) provided with this kit warns the user, "indwelling catheter should be routinely inspected for desired patency, security of dressing, and possible migration." a device history record review was performed, and no relevant findings were identified.Without the device to evaluate, the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.Associated mdr#s for the two devices reported: 9680794-2023-00480.
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