An event regarding glue reside on the inner blister involving a trident insert was reported.The event was confirmed by product inspection.Method & results: -product evaluation and results: the inner blister was returned with the box, ifu and device however, the tyvek sheet was not returned.Residue is visible on the center of the lid of the inner blister.A material engineer indicated that the debris from the sample was consistent with tyvek.See materials engineering request document in nc.-clinician review: not performed as medical records were not provided for review.-product history review: a device history review confirmed all devices accepted into finished goods conformed to specification.-complaint history review: 1 other event was reported for the lot indicated.Conclusions: the event for glue residue on the inner blister was confirmed by product inspection.Residue is visible on the center of the lid of the inner blister.A material engineer indicated that the debris from the sample was consistent with tyvek.Corrective action/preventive action: nc was created for tyvek sheet residue on inner blister lid.The nc noted, ¿the retainer within the inner sealed blister showed a white residue which is characterized as a glue-like substance (tyvek residue) on the retainer.The quality monitoring and post market surveillance team completed a fourier-transform infrared spectroscopy (ftir) test and confirmed that the substance is coming from the tyvek.The white substance is fixed on the retainer (no loose particulates) and, therefore, no substance would be in contact with the implant.The visual defect also does not affect the integrity of the sterile barrier system (sbs).Therefore, the sbs still meets its intent from a seal strength and seal integrity perspective and maintains the product sterility within the package.In the event that the sealing process creates this glue-like substance defect on the retainer, this defect would be even more noticeable by the or staff once the inner blister was opened.Per ifu 4350, ¿the packaging of all sterile products should be inspected for flaws in the sterile barrier before opening.In the presence of such a flaw, the product must be assumed nonsterile.¿.
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