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 was confirmed; however, the root cause was not identified.The product returned for evaluation was one 20ga x 0.75¿ safestep safety infusion with y-site.Usage residues were observed throughout the sample and the safety mechanism was engaged.Multiple cracks were observed in the white portion of the y-site valve housing.Microscopic inspection of the y-site confirmed multiple cracks in the white portion of the housing.Discoloration was observed in the vicinity of the cracks.An attempt to infuse water through the sample using a 12ml syringe revealed the sample to be patent to infusion; however, during pressurization, a leaks were observed at the cracks in the y-site housing.Y-site damage, resulting in device leakage, was observed during evaluation.The discoloration accompanying the cracks suggested that an unidentified environmental factor(s) may have contributed.Consequently this complaint is confirmed as ¿cause unknown¿ at this time.H3 other text : evaluation findings are in section h.11.
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