Information was received indicating that during use of this smiths medical cadd administration sets, leaking was noticed.It was reported that the sets "luer connection was not fitting (to small) to pivc, bung or another connector caused leakage".Reported that there was no patient involvement.
|
Other, other text: a sample was received to perform an investigation.The sample was visually inspected at a distance of 12 to 16 inches under normal conditions of illumination.The anti-siphon valve (asv) from the sample received was compared with a product floor sample and found that the nozzle from the valve of the returned sample was bigger.A device history record (dhr) review was performed which indicated all inspections were completed and no issues were noted during manufacture.The most probable root cause was that the asv was received defective from the supplier.A supplier corrective action report (scar) was issued to address possible causes.Additional information b4, d10, g1, g4, g7, h2, h3 and h6.This remediation mdr was generated under protocol b10009406, as a result of warning letter cms# 617147.
|