The lot number was reviewed for complaint trend, nonconforming report and capa.Devices met specification prior to release and no trends were noted.The device has been received at coloplast; however the evaluation is not yet complete.Without the benefit of examination and testing, coloplast is precluded from commenting on the condition of the device or the cause of the occurrence.Once our evaluation is complete, 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, two cylinders, and a reservoir were received for evaluation.Testing revealed a separation on the cylinder 2 exhaust tubing at the tubing/strain relief junction.This was a site of leakage.Microscopic evaluation revealed surfaces of the separation site to be rough and irregular, indicating sufficient stress was exerted to separate the site.Microscopic evaluation revealed surface abrasion on cylinder 1 and cylinder 2 strain relief and both exhaust tubing, indicating repetitive contact of surfaces.No functional abnormalities were noted with the pump, cylinder 1 or the reservoir.Based on examination of the returned product, it was concluded that while in-vivo all of the pump tubing had overlapped and abraded against one another.This positioning, in combination with device usage over time, could contribute to sufficient stress(s) to cause a separation in the cylinder 2 exhaust tubing at the tubing/strain relief junction.A separation of this type could then allow the loss of fluid, making the device inoperable.A review of the device history record confirmed the devices from this lot met all specifications prior to release.A review of the complaint history database, non-conformances and capas revealed no trends for this lot.
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