A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.A product sample was received for evaluation.Visual and functional testing were performed.Visual inspection found the first photo shows a fragment of the tray lid and the second photo shows the tray with two components.One of the components appeared to be compromised.Evaluation of the provided samples with unaided eye found two devices, one of the devices was observed to be broken and the wire was stretched.Review of the bill of material for tray part and the set up picture, included in device history record (dhr) found no components that could be matched with the returned samples.These samples do not resemble the needle nor the catheter from the affected tray.The provided samples are not provided as a part of the tray.The root cause of the reported issue was found to be not relevant to this manufacturer medical product.This remediation mdr was generated under protocol b10009406, as a result of warning letter cms# 617147.
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