As the lot number for the device was not provided, a manufacturing review could not be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.Journal article citation: martynov, i., raedecke, j., klima-frysch, j., kluwe, w., & schoenberger, j.(2018).Outcome of landmark-guided percutaneously inserted tunneled central venous catheters in infants and children under 3 years with cancer.Pediatric blood & cancer, 65(10).Doi: 10.1002/pbc.27295.
|
It was reported in an article from the journal of american society of pediatric hematology/oncology titled " outcome of landmark-guided percutaneously inserted tunneled central venous catheters in infants and children under 3 years with cancer " that after tunneled central venous catheters (tcvc) insertion in pediatric patients, catheter-related bloodstream infection and/or local skin inflammation (exit-site infections and/or tunnel infections) originating from the catheter, leading to device removal was identified in 16 patients.During catheter insertion, conversion to cut-down venotomy was necessary in one patient.The status of the patients and intervention details were not provided.
|