A titan touch pump and two cylinders were received for evaluation.Quality concluded that creasing fatigued the material over an extended period of time and most likely resulted in the noted confined abrasion and eventual separation of the cylinder # 1 exhaust tubing.A separation of this type would allow the loss of fluid, rendering the device inoperable.Management routinely reviews events such as this and monitors complaint levels.Additionally, events of this type relating to tubing fracture are captured in the product risk documentation and are addressed in the literature that accompanies the device.Based on this, no further corrective action is required at this time.See attached letter from fda dated 06/23 indicating fda has determined coloplast no longer qualifies for participation in the asr exemption #(b)(4) program.Effective immediately, we are required to electronically submit individual adverse event reports for these product codes.
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