The investigation found that the returned sample was not a 20g x 1.16in.Catheter.Measurements suggested the catheter could be from a 20g x 1.88in.Unit.This supplemental is to capture the unknown material number for the returned sample.H.6.Investigation summary: our quality engineer inspected the sample submitted for evaluation.Bd received one used insyte autoguard catheter tubing with no product documentation or packaging.A gross visual inspection of the returned sample found that the catheter tubing length was larger than the length of the reported product.The reported material number was for a 20g x 1.16in.Catheter.A measurement with a ruler found that the returned catheter tubing measured 1.80 inches, indicating that the catheter was likely a 20g x 1.88in.Unit as that is the only larger size available for a 20g unit.The total length of the catheter tubing for a 20g x 1.88in.Unit, including the material inside the nose of the adapter, is larger than 1.88 inches.As the returned sample was only 1.80 inches in length, it was concluded that the returned sample was missing some material.Microscopic inspection found that the missing end of the catheter tubing had an angled shape.The surface with the missing end was mostly a smooth surface with sections of rough surface near the outer diameter.This indicated that the catheter was likely partially cut by a sharp instrument, creating the smooth surface, and then experienced tensile stress that broke the catheter tubing, causing the rough surface.Based on appearance and shape of the cut, the most likely root cause was determined to be coming into contact with a sharp instrument (e.G., scissors) during use.Scissors or other sharp instruments may damage the catheter if used at or near the insertion site.It is also possible the damage could have occurred due to the needle piercing through the catheter during venipunture; however, the characteristic v-shaped cut was not present.Also, it is unlikely that the torn edge of the tubing would look smooth and uniform if the flexible tubing material was bent, stretched, and pulled over time.A device history record review could not be performed as the lot number is unknown.H3 other text : see h.10.
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