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), applicable manufacturing records, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of difficulty splitting a microintroducer was confirmed and appears to be manufacturing related.One 4.5 fr x 10 cm microez microintroducer was returned for evaluation.The grey sheath was fully peeled and the dilator was not returned.Blood residue and evidence of use was present on the device.One of the orange peel tabs was found to contain a concentric ring of material at the splitting interface.The material present on the tab was not even with the material present on the second tab.The uneven split of the tabs and presence of a ring in the material likely contributed to the difficult removal of the tab from the catheter; therefore, the complaint is confirmed.Bd is working closely with the manufacturing facility to prevent reoccurrence of the reported event.H3 other text : evaluation findings are in section h.11.
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