One single dpt kit with an iv set and pressure tubing were returned for examination.The reported event of ¿black particle was found inside the pressure tubing¿ was confirmed.One black material was observed inside of the tubing, on the inner tubing wall, at approximately 28.5cm proximal from the male connector, which was connected to stand-alone three-way stopcock.The black material was approximately 0.5mm x less than 0.5mm in size.The material stayed at the same location inside of the pressure tubing after 5 minutes of continuous flushing.The pressure tubing was cut, and the material was found embedded within the inner tubing wall, but a part of the material surface was exposed from the wall.Per chemistry study, the black material could not be identified because of low absorption energy.An engineering investigation has been initiated to consider any potential manufacturing factors that may have contributed to this complaint and implement any necessary corrective actions.A review of the manufacturing records indicated that the product met specifications upon release.It is common clinical practice to inspect all products before usage.Additionally, these products are used by highly trained clinicians, experienced in identifying and mitigating any hazards that arise.Invasive procedures involve some patient risks.Although serious complications are relatively uncommon, the physician is advised to consider the potential benefits in relation to the possible complications.In this case, the particulate was noticed before use.Complaint histories for all reported events are reviewed against trending control limits on a monthly basis, and any excursions above the control limits are assessed and documented as part of this monthly review.
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