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, applicable previous investigation(s), sample analysis, applicable fmea documents, applicable manufacturing records, and labeling.Based on a review of this information, the following was concluded: the complaint of a leak in the y-site was confirmed; however, the exact mechanism could not be determined.Three huber plus infusion sets were returned for investigation.A microscopic examination of the y-site revealed that the valve housing was out of round.A luer taper gage could not be inserted into the y-site due to the deformation of the valve housing.A functional test revealed fluid leaking from the y-site valves due to the deformation in the valve housing.A review of the manufacturing records showed that the lot met all release criteria.The huber plus infusion sets are 100% leak tested during the manufacturing process.It appears that the y-site valve housing was deformed after the manufacturing process and testing.It is possible that the deformation was caused if the product was exposed to excessive heat outside bd control; however, it could not be determined where or how the product was damaged.H3 other text : evaluation findings are in section h.11.
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