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 foreign material in the device was unconfirmed because the problem could not be reproduced.The product returned for evaluation was one 21ga safety introducer needle.The sample appeared free of obvious usage residues and the safety mechanism was not engaged.A region of what appeared to be material discoloration was observed at the interface between the luer material and the needle shaft.Microscopic inspection of the sample confirmed a region of material discoloration at the luer/needle interface.Following bisection of the sample within the discolored region, inspection of the material did not reveal any obvious deformation.The reported ¿white substance¿ appeared to be referring to the observed region of material discoloration.Such discoloration may be the result of internal stresses experienced by the luer polymer material during or following device manufacture, but did not appear cause any device defect or disfunction.Consequently this complaint is unconfirmed at this time.A lot history review (lhr) of reen3317 showed no other similar product complaint(s) from this lot number.
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