The following were reviewed as part of this investigation: patient severity, frequency analysis, applicable previous investigation(s), sample (if available), applicable fmea documents, labeling, and applicable manufacture records.Based on a review of this information, the following was concluded: the complaint of a compromised seal between the tyvek lid and the rigid plastic tray was confirmed and the cause appeared to be associated with prolonged exposure to excessive heat.The source of heat was inconclusive.Two photographs were provided for investigation.The physical samples were subsequently returned.All six huber plus trays from lot rebt0392 exhibited deformation, which appeared to a result of heat damage.The flanges were curled and the preformed features of the rigid tray were warped.Five of the six huber plus trays exhibited a breach in the sterile barrier.It appeared that the deformation of the tray caused portions of the tray flange to separate from the tyvek lid.Other portions of the lid remained sealed to the tray.The exposed portions of the tray flanges revealed evidence of material transfer where the tyvek lid had once been sealed to the tray flange.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 bard control.Autoclaving can also cause excessive heat.The trays should not be re-sterilized.The case label for this product states, ¿do not use if package is damaged¿.
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