The device involved in the incident was not removed and remains implanted in the patient and in use.No evaluation of the device can be performed.The device was implanted for 1 year 18 days prior to the incident.No reports of a similar incident with this device have been received.Attempts to obtain additional information regarding the incident were unsuccessful.The female luers are manufactured to meet the iso standard (iso 594-2:1998).They are universal female luers and will mate with any universal male luer of the bloodlines, syringes, injection caps, etc.If they are also manufactured to the iso standard.Without an evaluation of the device the investigation cannot determine if the failure was related to manufacturing.It is unlikely due to the device having been in use and continues to be used with no reported problems.It is possible the connection to the blood line was not fully secured at the onset of the hemodialysis treatment.
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