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, applicable previous investigation(s), sample analysis, applicable fmea documents, applicable manufacturing records, and labeling.Based on a review of this information, the following was concluded: the complaint that the packaging was unsealed before use was inconclusive due to the sample condition.One groshong nxt clearvue catheter kit was returned for investigation.The outer packaging with the label was returned with various components from the kit.The outer packaging had been opened.The tyvek flap remained attached to the top edge of the pouch.Evidence of a complete seal was observed where the tyvek had been peeled away from the pouch.A white colored band that was 12.5mm to 14mm in width was observed along the edge of the pouch where material was transferred from the tyvek flap.No gaps were noted in the material transfer along the edge of the pouch.No other damage was observed on the tyvek or pouch.The inner tray was not returned for investigation, but two photographs that were provided for investigation showed the inner tray within the outer packaging.The tyvek appeared to be partially removed from the inner tray.A tactual investigation revealed that the remainder of the seal was intact and the tyvek was adhered to the bag.The packaging exhibits evidence that it was properly sealed, but may have been inadvertently opened outside bd control.Potential contributing factors of the reported damage include handling or storage conditions; however, the exact cause of the complaint could not be determined.
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