H11: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.The following were reviewed as part of this investigation: patient severity, complaint and lot history review, applicable previous investigation(s), sample (if available), labeling, applicable manufacture records, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of open kit seal is confirmed; however, the exact cause is unknown.One 3 fr single lumen provena midline catheter kit was returned for evaluation.An initial visual observation showed the top edge of the kit was returned open; this opening in the packaging was observed to be on the top edge of the tyvek instead of the lower edge of the tyvek, which is the location where the packaging is intended to be open.A solid, unbroken band of seal transfer residue could be seen on the entire length of the clear film of the opening in the packaging.The lidocaine vial and all three chloraprep devices within the kit were found to be broken and empty.The kit tray was observed to have been crushed near its center, apparently from beneath.The damage to the kit tray and the glass components within the kit suggest the opening in the kit packaging was most-likely caused by a sudden, forceful impact which also caused the packaging to burst along its sealed upper edge.However, it was not possible to determine when or where the kit experienced such an impact.This damage could have occurred during transit, handling, or storage.No evidence was found to suggest the kit was not properly sealed prior to when this damage occurred.
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