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, trend analysis, applicable previous investigation(s), sample (if available), and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a missing needle cover was inconclusive due to the condition of the returned sample.The product returned for evaluation was one 22ga x 0.75¿ safestep safety infusion set.The sample was received with its original opened packaging.The clear plastic needle cover was not present on the needle or in the packaging.While no needle cover was observed, the opened state of the packaging prevented determination of the original state of the device.Consequently this complaint is inconclusive at this time.A lot history review (lhr) of asdss0184 showed no other similar product complaint(s) from this lot number.
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