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 an open package is confirmed and appears to be manufacturing related.One 22 ga huber plus was returned within its packaging.The product label indicated lot: refp1452.No apparent warping or deformation was noted on the kit packaging.The lower section of the lid was observed to not be adhered to the plastic tray flange.No evidence of seal transfer material was noted on the tray flange where the lid was not adhered to.The lid was peeled off a section that was adhered.The newly peeled region revealed seal transfer material to be left on the tray flange.The photos of the sample were sent to the manufacturing facility.The manufacturing facility confirmed the issue of the lid tray not being completely adhered to the lid tray; therefore, the complaint is confirmed.Bd is working closely with the manufacturing facility to prevent reoccurrence of the reported event.A lot history review (lhr) of refp1452 showed no other similar product complaint(s) from this lot number.
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