As follow-up of a previous report that an extension set split and leaked, the customer reported that an extension set was checked to see if the tubing comes apart.The tubing came apart but with a lot of force, and as a result the tubing was separated.There was no patient involvement.No additional information is available.
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One unused sample was received for evaluation.Visual inspection was performed and it was observed that the tubing was separated from the male luer.Insertion testing and dimensional testing were performed with no issues noted, and the sample met specifications.If the connections (tubing-rigid components) are pulled with a force greater than 5 pounds, a separation or tubing break can occur, thus, it can be concluded that the reported condition is the effect of the force applied by the costumer in the junction between the tubing and male luer.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.
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