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.A lot history review (lhr) of asfxf020 showed no other similar product complaint(s) from this lot number.The following were reviewed as part of this investigation: patient severity, complaint and lot history review, applicable previous investigation(s), sample (if available), applicable manufacture records, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a cracked hub was confirmed; however, the exact cause is unknown.Two photographs of a 20 g powerloc max infusion set with a y-site were returned for evaluation.An initial visual observation of the photographs showed a relatively large longitudinal crack in the y-site of the infusion set.This crack was observed to begin at the proximal end of the y-site and continue through the treading to the middle of the hub, but terminal proximal to the branch in the y-site.No additional damage could be seen on the threads of the y-site.Use residue could be seen on and within the sample in the returned photographs, and the safety mechanism was observed to be engaged over the needle tip.While the exact cause of the crack in the y-site of the sample in the returned photographs could not be determined, possible contributing factors include over-tightening, forceful insertion of a tapered object into the luer hub orifice, and exposure of hub to incompatible chemicals.H3 other text : evaluation findings are in section h.11.
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