As reported, during fixation two petals separated from the perfix light plug, the issue was not reported as an out-of-box event.Inspection of the returned sample finds the perfix light plug has evidence of handling and is contaminated from attempted use.The sample was found to be inverted and there are two petals torn from one of the inner plugs.There is some fraying along the edge of one of the loose petals returned.Based on the reported event and condition of the sample as received the separation of the petals most likely occurred inadvertently due to user/device interface while suturing and forces applied during placement of the plug.Review of manufacturing records confirms product was manufactured to specification.To date, this is the only reported complaint for this manufacturing lot of (b)(4) released for distribution in december 2022.Note: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.H3 other text: sample evaluated.
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