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 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 detached retainer is confirmed and was determined to be manufacturing related.Three picc plus statlock devices with tricot pads and adjustable posts were returned for evaluation.An initial visual observation showed use residue on the returned samples.The retainer of one sample was observed to be completely detached from its pad, and a microscopic observation revealed insufficient adhesive coverage on the underside of the detached retainer.The retainers of the other two samples were observed to be intact, but the right side of each of these retainers was found to detach slightly from the pad when a small amount of force was applied.Strings of adhesive were observed between the retainer and the pad of these two samples.The investigation was forwarded to the manufacturing facility for further evaluation, and bd is working closely with the manufacturing facility to prevent recurrence of the reported event.
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