Information was received that a smiths medical portex blue line tracheostomy tube inner cannula was found to be the wrong size, the size 8.0 inner cannula contained the 9.0 size instead.The problem was discovered in use, while attempting to fit the product with a patient's tracheostomy (trach) tube.To resolve the issue, the patient's nurse was able to use another inner cannula from the same lot that was the correct size.No adverse patient effects were reported.
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This mdr was generated under protocol b10009704, as a result of warning letter cms# 617147.G5 510k is unknown.No information has been provided to date.A review of the device history records showed there were no observations recorded during manufacture to suggest an issue of this nature would occur with this lot of product.The returned sample consists of one cannula, the returned sample was received in used conditions without its original packaging.Visual inspection was performed at a distance of 12 to 16 inches and normal conditions of illumination and it was observed that the part number indicates an 8.0 mm inner cannula and the cannula packaged was a 9.0 mm inner cannula.The root cause is due to manufacturing.Retraining to the production personnel was conducted by quality engineer.Updated g1 contact name updated h3 device evaluated by manufacturer updated h6 event problem and evaluation codes updated h10 additional manufacturer narrative.
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