The following were reviewed as part of this investigation: patient severity, complaint and lot history review, applicable previous investigation(s), sample (if available), labeling, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a picc causing or contributing to a reaction in a patient is inconclusive and could not be verified from the returned photograph.One photograph of what appears to be a patient¿s arm was returned for evaluation.An initial visual observation of the photograph showed some of the skin of the patient¿s arm appeared to be darkened and possibly damaged; however, the returned photograph was out of focus and very little detail could be discerned.No catheter could be identified in the returned photograph.No further action is required because the reported event could not be related to a deficiency in product manufacture or deficiency while under correct product use.While the cause of the reported patient reaction could not be determined from the returned photograph, possible causes of irritation, infection, or other such reactions include, but are not limited to contamination of the insertion site, exposure to harsh chemicals, and patient condition/sensitivities.As a note, vad products are sterilized using ethylene oxide (eo).The sterilization cycle has been validated by the very conservative over-kill (half cycle) method in accordance with ansi/aami/iso 11135:2014 annex b sterilization of health care products¿ethylene oxide¿requirements for development, validation and routine control of a sterilization process for medical devices (fda consensus standard as of (b)(6) 2016).Validation and revalidation have demonstrated that the sterilization cycle exceeds the minimum sterility assurance level of 10^-6.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.
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