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, applicable previous investigation(s), sample analysis, applicable fmea documents, applicable manufacturing records, and labeling.Based on a review of this information, the following was concluded: the complaint of a detached sheath is confirmed but the exact cause remains unknown.One 4.5 fr x 5 cm microez microintroducer was returned for evaluation.The sheath was returned fully peeled.One of the peel tabs was detached from the proximal end of the sheath material.Microscopic observation of the peel tab revealed a slot in the inner portion of the peel.The presence of the slot suggests the sheath was attached to the tab during manufacture of the device.A non-complainant sample was inspected.A tensile/upward force was applied during peeling to the non-complainant sample which resulted in detachment of the sheath from the tab.The characteristics of the non-complainant sample resembled the characteristics of the returned sample.Based on the characteristics of the sheath and tab, likely contributing factors include application of a tensile force during peeling of the sheath.Since the sheath from the returned sample was detached from the tab, the complaint is confirmed; however, the exact factors leading to the detachment remain unknown.H3 other text : evaluation findings are in section h.11.
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