It was reported that during a dialysis catheter placement procedure, the device allegedly had problem with leads when using the internal jugular vein because it forks.It was further reported that the split tip opened at the superior vena cava and it kept on engaging the right atrium lead that was turned up into the right atrium.Reportedly, the catheter was pulled up into the neck, torqued it clockwise to get the tips rotated ninety degrees and then pushed it back in.There was no reported patient injury.
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H10: as the lot number for the device was not provided, a review of the device history records 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.H11: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.H3 other text : device not returned.
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