Other, other text: four samples were received to perform an investigation, three of the samples were unused.It was observed on the used sample that the union between stopcocks was broken.Broken sample was inspected under magnification, an elongation was identified in the broken section on one of the stopcocks and on the other stopcock remaining material was observed.Multiple tests were run on the samples which determined that root cause could not be attributable to manufacturing.The most likely root cause was mishandling during use, as an applied force was required to break the devices.The root cause of the problem was determined to be user interface.This remediation mdr was generated under protocol b10009406, as a result of warning letter (b)(4).
|