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.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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A titan otr pump, two cylinders, and a piece of detached inlet tubing were received for evaluation.Examination and testing of the returned components revealed a separation at the strain relief of the longer exhaust tube of the pump.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 tubes and all strain relief of the pump and on the detached inlet tube.Partial separations within abrasion are noted on the longer exhaust tube of the pump.Testing revealed these not to be sites of leakage.Tissue is noted in the detached inlet tube.No functional abnormalities are noted with cylinder #1 or cylinder #2.Based on previous quality simulations and examination of the returned product, quality concluded that the rough and irregular surfaces associated with this separation indicates that sufficient stress(s) was exerted at the strain relief of the longer exhaust tube of the pump to separate the site while in-vivo.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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