Device evaluation: result - the customer returned (2) loose 1cc, 8mm syringes.Customer states that the needle separated from the hub and stayed in the site.Both returned syringes were examined and one sample exhibited a broken cannula.Microscopic examination of the returned sample revealed characteristics such as residual bends on the broken hub end, cracked adhesive and tubing ovality (deformation from the normally circular cross section).When viewed together, these are all indicators of bending/re-straightening mode of failure.Removal of some of the adhesive made this observation more apparent.The shield was also examined for any possible scrapes or cuts related by cannula recapping or improper shielding, however nothing was observed.Conclusion - bd was able to duplicate or confirm the customer¿s indicated failure of needle break off.From the investigation conducted, the root cause appears to be re-use.
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