Other, other text: one picture and one sample was returned for evaluation.A small split was observed in the middle of one eyelet in the picture.During inspection of the returned sample, a cut in the flange corner could be seen confirming the complaint.Based on the analysis conducted in the sample provided, the failure of broken flange was confirmed.Therefore, according to on pfmea (rmd-10001943) and ifu (10018858-001) the occurrence of this failure condition could be caused by: velcro or metal clips from tracheostomy holders which may have sharp edges which can come into contact with eyelets and compromise the product integrity.Molding related process.All mitigations on placed were verified and it was confirmed has been executing according, therefore no corrective actions could be implemented, it will be continue monitoring this failure condition in this product for threshold or escalation.
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