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 an open seal was confirmed and the cause appeared to be manufacturing related.One unit pouch for statlock stabilization device was returned for investigation.The product code and lot number on the packaging was art0423 and juctf523, respectively.The pouch contained 2 foam strips.The pouch contained the skin preparation pad.The statlock stabilization device was missing from the pouch.The end of the pouch, opposite from the chevron seal, was open.No evidence of a seal was observed at the open end of the packaging.The manufacturing facility was notified of this complaint.A lot history review (lhr) of juctf523 showed no other similar product complaint(s) from this lot number.
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