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), returned physical samples, applicable fmea documents, and applicable manufacture records.Based on a review of this information, the following was concluded: the complaint of detachment of the statlock retainer from the foam adhesive pad was confirmed and the cause was determined to be manufacturing related.The product returned for evaluation was two statlock picc plus catheter stabilization devices.One was returned with an opened pouch and another was returned sealed within the original pouch.No traces of product usage were seen on the opened sample.The opened sample was confirmed to contain a statlock retainer which was partially detached from the foam base.Further evaluation of the foam pad and mating retainer base found that adhesive had been consistently applied but did not adequately join the two components.The sealed sample was then opened and inspected and it was determined that adhesive application was likewise consistently applied.Very little force was required to pull the retainer up from the foam pad and the pad did not tear during the action.The fact that the retainer could be easily detached, without tearing the foam pad, confirmed that the bond between the two components was inadequate and that the cause was likely related to the manufacturing process.The sample photographs were then submitted for review and evaluation by the manufacturing facility.Bd is working closely with the manufacturing facility to prevent recurrence of the reported event.H3 other text : evaluation findings are in section h.11.
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