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 nature of the returned sample.The product returned for evaluation was one 22ga x 0.75¿ safestep safety infusion set.The sample appeared free of usage residues and was received with its original opened packaging.The needle cover was not returned for evaluation.While the cover was not returned for evaluation, the opened state of the packaging prevented determination of the original state of the device.Consequently this complaint is confirmed as ¿cause unknown¿ at this time.A lot history review (lhr) of ascts0145 showed no other similar product complaint(s) from this lot number.
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