We have concluded that this incident involved a possible design flaw of the connector to the port.As described by the surgeon, he feels that the blue connector was not a snug fit at the time of implantation and at the time of removal at the bedside the catheter slipped through the blue connector and remained within the subcutaneous tissue.The physician indicated there are three pieces to the port (the port, the connector, and the catheter/tip), the surgeon stated he thought upon removal, all pieces were intact.The blue connector was found when the patient underwent a pet scan.Once this was reported to the surgeon, the patient was taken to the operating room on (b)(6) 2020 for removal of the blue connector, which was found within the subcutaneous tissue.Fda safety report id# (b)(4).
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