It was reported while testing with bd bbl¿ mueller hinton ii agar two label were found to be illegible.There was no report of patient impact.The following information was provided by the initial reporter: on november 25, the suprom client notified a complaint, about the reception of the product with the illegible label, catalog: 211438, lot: 1131296, 02 bottles.
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It was reported while testing with bd bbl¿ mueller hinton ii agar two label were found to be illegible.There was no report of patient impact.The following information was provided by the initial reporter: on (b)(6) 2022, the suprom client notified a complaint, about the reception of the product with the illegible label.Catalog: 211438.Lot: 1131296.(b)(4) bottles.
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H6: investigation summary: this response is to summarize findings on your complaint related to bottle mueller hinton ii agar 500g, catalog number 211438, batch 1131296, complaint #(b)(4) for unsatisfactory product labeling.Components are milled and blended (where required) and dispensed into containers.Following qc release, and based upon inventory demand, final packaging operations occur, which include dispensing into and labeling of final configurations, followed by transport to the distribution center.Where the final packaging configuration is terminally irradiated, packaged product is sent to the irradiator, then qc released prior to entry into inventory.The complaint investigation included a review of the batch history record (bhr) for bottle mueller hinton ii agar 500g, batch 1131296.All qc release testing including dehydrated medium appearance, solubility, prepared plate appearance, ph, and cultural response with those organisms specified on the bd certificate of analysis was satisfactory.Complaint trends were reviewed for a period covering 12 months.During that time, there have been no other complaints received on this lot for any defects.Two photos were received that both pictured bottles of 211438, lot 1131296 with portions of the vendor-printed labeling not printed.This complaint has been confirmed from the customer photos.Operators are responsible for ensuring bottles are appropriately labels when material is collected from the accumulation table and placed into shelf-boxes.The missing fields shown in the label are pre-printed by bd¿s label supplier, and batch specific information (black ink) is printed in-house.All labels affixed to the batch history record were satisfactory.No root cause has been identified for why the information was not printed by bd's label supplier.The customer¿s defect has been presented during packaging manufacturing meetings for awareness.No corrective actions are slated at this time.Bd will continue to monitor dcm complaints for labeling defects.
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