H11: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.The following were reviewed as part of this investigation: patient severity, trend analysis, applicable previous investigation(s), sample (if available), and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a cracked infusion set y-site luer was confirmed and the cause appeared to be supplier-related.The product returned for evaluation was two 20ga x 0.75¿ powerloc max safety infusion sets with y-site.The first sample (sample 1) exhibited usage residues throughout.Needleless injection caps were attached to both luer adapters.A longitudinally aligned split was observed in the y-site, extending from the orifice past the attached accessory.Microscopic inspection of sample 1 revealed that the split occurred along a molding weld line.The split surfaces were dull and granular.Sample 2 was received in its original sealed packaging.The sample was unused.Microscopic inspection of sample 2 confirmed a molding weld line in the y-site but was otherwise unremarkable.The crack occurred along a feature caused during the molding process.The device is a supplied component and corrective actions have been implemented by the supplier.The complaint sample was manufactured prior to implementation of those actions.H3 other text : evaluation findings are in section h.11.
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