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 at the y-site hub is confirmed but the exact cause is unknown.Two huber plus 20 ga x 1 in infusion set devices were returned in open packaging.Both trays exhibited deformation which appeared to be caused by heat damage.The flanges were curled and warped.The tyvek lid was returned peeled; however, evidence of a complete seal was observed.An inspection of the infusion sets showed the y-site hubs to contain an oval shaped deformation.The infusion sets were flushed with water and leaks were noted at the y-site hubs.Microscopic observation of the y-site revealed a gap between the blue valve and white housing due to the deformation.The exposure to heat appears to have affected the warping of the tray packaging and infusion sets.This type of damage can occur from prolonged exposure to excessive heat, and the damage was most likely associated with shipping or environmental conditions outside bd control.H3 other text : evaluation findings are in section h.11.
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