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 corroded scalpel was confirmed and appears to be supplier related.One sealed 4.5 microez microintroducer kit was returned for evaluation.The product packaging label information indicated lot: recv0408.The package was opened, and the inner component packaging was also found to be sealed.All of the components were present.The protective cover was present over the scalpel; however, red-brown residue was visible on the blade.The inner packaging was opened in order to inspect the blade.Microscopic observation of the residue present on the blade revealed its characteristics to be similar to rust.Since the residue was present on a component contained within sealed packaging, the complaint is confirmed.Photos of the sample will be forwarded to the manufacturing facility for further review.Reynosa evaluation: complaint due to ¿blade of scalpel rusted¿ was confirmed.According with the photo evaluation performed at reynosa facility and gross visual evaluation, microscopic visual evaluation performed by vad field assurance the following was concluded: the scalpel was found to be corroded along the entire blade.This condition makes the device unsafe for our customer.Therefore, the cause of this condition is supplier related.An incident report was issued to notify our supplier about this issue.
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