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 no marks on the catheter is inconclusive due to poor sample condition.One photo sample of a catheter segment was returned for evaluation.The catheter appeared to have been trimmed at both ends.The segment location of the catheter could not be determined as the depth markers were not visible in the image.The condition of the catheter segment shown could not be fully inspected from the image provided.Based on the information provided, possible contributing factors include depth marker fading during use, exposure to incompatible cleaning solutions, and missing print during the catheter printing process.Since the reported issue and cause of the issue could not be confirmed from the image provided, the complaint remains inconclusive at this time.
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