Without the benefit of examination and testing, coloplast is precluded from commenting on the condition of the device or the cause of the occurrence.Should additional facts prompt us to alter or supplement any information of conclusions contained in the original mdr or in any prior supplemental reports, a follow-up report will be submitted.
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This follow-up mdr is created to document the evaluation of the returned device: a titan touch pump and two cylinders were received for evaluation.Examination and testing of the returned components revealed a separation at the strain relief/exhaust tube junction of cylinder #2.Testing revealed this to be a site of leakage.The separation appears to be rough and irregular, indicating sufficient stress was exerted.Surface abrasion is noted on all strain relief and all tubes of the pump.No functional abnormalities are noted with the pump or cylinder #1.Based on quality's examination, quality concluded that while in-vivo both the exhaust tubes and inlet tube positioned themselves in such a way that caused them to overlap and abrade against one another.Quality further concluded that this positioning, in combination with device usage over time, could contribute to sufficient stress(s) to separate the exhaust tube of cylinder #2 at this site.A separation of this type would then allow the loss of fluid, making the device inoperable.Management routinely reviews events such as this and monitors complaint levels.Additionally, events of this type are captured in the product risk documentation.Based on this information no further corrective action is required at this time.
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