One used cadd® administration set was returned for investigation.A visual inspection was performed to look for damage, cuts, holes, or anything that could cause a leak.During inspection, delamination was found in the bonding union with the pump tube and the 12" extension tube.Functional testing was performed, and the device leaked on the bonded joint between the pump tube and 12" tube.A manufacturing review of a similar device was performed and no discrepancies were found.The most probable root cause was determined to be that the manufacturing production personnel did not verify that the solvent bond between the tubes did not have any delamination or voids.The complaint was confirmed.
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