Other text: additional information: h6, h10: device evaluation: four smiths medical cadd cassette reservoir were returned for analysis in a used condition.Visual inspection was performed and indicated that the sample using did not present any damage, scuffs, pinch marks, cracks, crazing, cuts, etc.That could cause the failure mode reported.During functional testing, leak testing on the unit received was performed and the sample was rejected by leak test equipment.Leak was noted in the join with the tube of the bag; therefore, it confirmed the failure mode reported.Based on the evidence, the complaint was confirmed, and the problem source of the reported event was noted to be manufacturing.
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