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 batch history, applicable previous investigation(s), sample analysis and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of an unprotected sharp in the device packaging was inconclusive due to the sample condition.A 22g x 0.75¿ safestep safety infusion set was returned with its previously opened packaging.The safety mechanism was returned fully activated over the needle bevel.No apparent evidence of use was noted on the device and no damage was found on the device or packaging.The packaging needle cover was returned separate from the needle.The safety mechanism was deactivated by the investigator in order to inspect the needle.No bends in the needle shaft were observed.The needle was able to be inserted into the needle cover with a tight fit.The complaint of an unprotected sharp in the packaging could not be independently confirmed without evaluation of a sealed kit; however, the report of an unsafe sharp has been documented and included in complaint trending.This type of complaint will continue to be monitored as part of ongoing efforts to identify potential manufacturing or packaging related issues.
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