Duoderm paste (1tubex30g) was manufactured under sap code 1000894 and manufacturing lot number 0a01790 on 30 jan 2020.Lot # 0a01790 was sterilised under reference (b)(4).And released on review of results of sterilisation provided by sterilisation company steris.All the results were within specification and products were released.No nonconformity was identified during the manufacturing process of lot 0a01790.This is the third complaint for the affected lot registered within tw10.2.The two other complaints are related to stained market boxes (tw(b)(4).And tw (b)(4).The complaint issue shown is associated with the issue in nonconformance tw(b)(4).And previous complaints received for greasy tubes and stained boxes.No additional investigation was required as the complaint issues has occurred previously and the reason is understood.What was described as water droplets in the complaint intake is most likely propylene glycol, which is a viscous, colourless liquid.This is an oily substance to touch and is also most likely the cause of the stained market boxes, as it is known to get trapped in the tube crimp and leak out.It is unlikely the substance is water, as while sterilisation (steaming) would have introduced water, this is unlikely to still be on the surface of the tubes 2 years after manufacture unless other local environmental conditions had introduced condensation.24 photographs were received for this issue and have been evaluated in accordance with (b)(4).The photographs confirm the expected lot number, product and the complaint issue where droplets of liquid can be seen on the surface of a tube.The liquid is not, however, water.4 photographs supplied by the complainant show tertiary packaging bearing a label stating the contents as batch 9b03392.It is questioned if this box has been repackaged and relabeled and when this occurred.If the boxes have been removed and relabeled, there is no guarantee that they have been placed back into the cartons in the same orientation that they should be.It is questioned if the boxes were discoloured and greasy at the time of relabeling, or if this has occurred after relabeling.This paste product has since been discontinued.No further action is required or possible due to the manufacturing line having been removed from deeside.Should additional information become available, a follow-up report will be submitted.Fda registration number: reporting site: 1049092.Manufacturing site: 1000317571.
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