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), labeling, applicable manufacturing records, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a buckling introducer was confirmed.One 3.5 fr microintroducer was returned for evaluation.The dilator was returned within the sheath.Blood residue was present throughout the device.The pull tabs were had not been peeled.The sheath and dilator shafts were observed to be bend and curved.Microscopic observation of the distal tip of the sheath revealed a section to be deformed.The deformed section was bunched back.The deformation visible on the distal tip and bends in the microintroducer shaft suggest the device experienced resistance during advancement.The product instructions for use (ifu) contains information which may have prevented the resistance contributing to the microintroducer sheath damage.The ifu states, "advance the small sheath and dilator together as a unit over the guidewire, using a slight rotational motion.If necessary, a small incision may be made adjacent to the guidewire to facilitate insertion of the sheath and dilator.Verify institutional guidelines concerning the use of a safety scalpel prior to making incision." a review of the manufacturing records did not reveal evidence to suggest a manufacturing related root cause contributed to the reported event.Since evidence of resistance during advancement and damage to the microintroducer was observed, the complaint is confirmed.A lot history review (lhr) of reeq2429 showed no other similar product complaint(s) from this lot number.
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