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 lot history, applicable previous investigation(s) and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of an open seal was confirmed and appears to be supplier related.One 20 ga x 0.75 in safestep infusion set was returned for investigation.The needle protective cover was observed to be caught within the seal, causing an incomplete seal.The remainder of the seal was intact.The tyvek lid was partially torn due to being compressed against the protective cover.Based on the condition of the returned sample, the complaint was confirmed.The supplier has been notified of this complaint.A lot history review (lhr) of asdqs0190 showed no other similar product complaint(s) from this lot number.
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