The following were reviewed as part of this investigation: patient severity, trend analysis, applicable previous investigation(s), sample (if available), and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a damaged infusion set was confirmed.The product returned for evaluation was one 20ga x 0.75¿ powerloc max safety infusion set.Usage residues were observed throughout the sample.A needleless injection cap was attached to the luer adapter and the safety mechanism was engaged.A partially circumferential split was observed at the luer/tubing joint.Microscopic inspection of the split revealed a granular fracture surface.Beach marks and radiating tear marks were observed throughout the fracture surface.Material buckling and discoloration were observed in the vicinity of the split.The split characteristics and material buckling were consistent with material failure due to repetitive stress.It appeared that the tubing fractured, in part, due to repetitive torsional (twisting) stress, suggesting that securement, access and maintenance techniques may have contributed; however, it appeared that an additional unidentified factor(s) may have contributed.The supplier has been notified of this even.A lot history review (lhr) of asfqf081 showed two other similar product complaint(s) from this lot number.The complaints for this lot number (asfqf081) have been reported from the same facility.
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It was reported "patient¿s lateral lumen broke at the very end closest to the microclave.When pushing a flush through the line, the line started leaking of the saline.No blood came back through the line when this occurred.Pt line was clamped pts lateral lumen was then deaccessed, accessed and cultures were drawn.No fluids were running at the time of the line break.We have the needle to return for investigation.No pt.Harm but potential risk line violation" it was reported this occurred with two devices.This report addresses the first device.
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