From the failure investigation and available information on the reported incident, the cause of complaint as described above could be the dimensional difference between coupling of the female and male luer fitting.Engineering evaluation have been carried out on the returned samples and compared with those on the stocks; the mold flow analysis conducted on the fitting and shown no stress point on the structure of the luer fitting.(see appendix a).Dimensional measurement was conducted on the inner surface of the female fitting and the male luer of the stopcock.Based on the dimensional analysis, the inner surface of the female luer fitting is between nominal to lower (i.E.Can be smaller in size).The male luer has a dimension that is nominal to high (i.E.It is bigger in size).Hence when these 2 parts are coupled together, the interference fitting between the parts can be extremely tight to no tolerance, thus, further tightening of the parts can result to crack on the component particularly on female luer fitting.Production associates were informed on the complaint and not to over tighten during assembly.
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