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 batch history, applicable previous investigation(s), labeling, applicable manufacturing records, sample analysis and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of an improper peel is confirmed and the cause appears to be manufacturing related.One 5 fr microez microintroducer was returned for evaluation.The sheath was returned fully peeled and the dilator was not provided the tab splitting surface revealed one tab to contain an uneven amount of the material.The extra material formed a complete ring which likely contributed to a difficult removal from the catheter.Based on the information provided, the characteristics of the material properties likely contributed to the uneven tab peel; therefore, the complaint is confirmed.Bd is working 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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