On 04oct2023, (b)(6) provided an excel sheet with information about avi catheters that needed to be removed due to various malfunctions.One of these was a report of thrombus at a dwell time of four days.On 23oct2023, (b)(6) provided additional details: the line was placed on (b)(6) 2023.The order stated that more access was needed.The patient received two doses of vancomycin, two doses of ampicillin, and a single dose of saline.The patient was discovered to have phebitis (inflammation of a vein near the surface of the skin) on 12jul2023, and the line was removed.As a result, the patient required two pivs and was discharged on lovenox, an anticoagulant used to treat and prevent dvt.(b)(6) noted that he's confident that the ifu was followed for proper care and maintenance during insertion, but he can't be sure about the level of maintenance after that unless he performs an audit.No photos were taken, and the device was discarded by the user and therefore unavailable for return to avi for further investigation.The lot number provided (#11473239) is assigned by (b)(4) (avi's approved supplier for kitting).This kit contained catheters from six different avi catheter lot numbers: #01052302, #12222205, #01162306, #12132202, #01252308, and #02162302.For this investigation, all six lhrs were reviewed.No discrepancies were identified that could potentially contribute to the complaint issue.With the limited information provided and no return of the device, avi is unable to determine root cause.It is not known whether the hydromid device contributed to the reported thrombus.
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