It was reported the mexico government sales area received a non-compliance report dated last (b)(6) 2022, regarding a pvc, portex, blue line ultra disposable tracheostomy cannula, with catalog no.100/810/080 and lot 4059501, sanitary registry (b)(4) ssa.The imss bidding event involves 41 pieces of the aforementioned device.8 pieces were analyzed by the laboratory of non-metallic materials of the division of healing materials and instruments of the imss (instituto mexicano del seguro social), which found that the samples of the product did not comply with the quality specifications of the cnis (national compendium of health supplies) and the feum-sdm-2017-4ed.; finding discrepancies in the internal and external diameters of the cannula (with values higher than those specified in the reference monograph) the endocanula internal diameter specification was 8,0 +/- 2 mm, and was found to have 8,3 mm.The external diameter specification was 11,3 +/- 0,5 mm, and was found to have 12,1 mm.The samples also presented leakage in the balloon of the cannula and its pilot balloon.Additional information received via email on 21-oct-2022: of the 8 pieces chosen, none of them meets the measurement standards in terms of internal and external diameter of the input, established in the supplement for medical devices, fourth edition of the pharmacopoeia of the united mexican states, mexico 2017.The tests are carried out on the balloons, found leaks in the balloon in 3 pieces and in the pilot balloon in 2 pieces.With these results, the rest of the tests established in the feum for the input were suspended and the entire batch was declared as not compliant.A picture of a table with the tests results was attached to the complaint object.No patient injury was reported.
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