E1: (b)(6).Based on the available information, this event is deemed to be a reportable malfunction.A batch record review was completed, and no discrepancies were found.All seal integrity tests completed throughout the batch manufacture were satisfactory.Aquacel ag+ wsf 1x45cm (1x5pk)ster eur was manufactured under systems applications and products in data processing (sap) code 1708336 and manufacturing lot number 3a03213 on 27 january 2023.This date is reflected as the start date if the batch, with the batch completed on 31 january 2023.This differs from dated in systems applications and products in data processing (sap), which identifies the batch manufacture date as 05 february 2023.This is the date the batch was released following the sterilization.Lot # 3a03213 was sterilized under run and released on review of results of sterilization provided by sterilization company steris.All of the results were within specification and products were released.No nonconformity was identified during the manufacturing process of lot 3a03213.This was the only complaint for the affected lot registered within database.Three photographs were received for this issue and have been evaluated in accordance with work instruction (wi).The photographs confirm the product, lot and expected complaint issue where a single open sachet can be seen.The open sachet contains a folded ribbon dressing which is caught in the seal and has discoloration identifying where it has been heat sealed into the sachet seal.A corrective and preventive actions (capa) has been raised recently for an open seal identified on a batch produced on the same manufacturing line (universal line).The investigation identified that the flipper cylinder on the line slowed down as fibre was catching pusher on the upstroke.The sensor guides were not lined up and first fold position and symmetry by moving securing clamps holding the reed switches.The process instruction for the line (pi12-028 v35.0) did not give adequate instructions for the set up of the cylinder fold sensors.It was also identified that operators were not trained against the pi12-028 or the standards of acceptability (wi-0521 v2.0).There have been no previous complaints for dressing in seal from the universal manufacturing line, and it was not appropriate to raise a new corrective and preventive actions (capa) while the corrective and preventive actions (capa) already open still has open actions being implemented.As no complaints have previously been received, the complaints per million (cpm) for this product and malfunction is zero, so would not have required a corrective and preventive actions (capa), and the occurrence is also below acceptable quality level (aqls).The implementation dates will be noted and any further complaints checked against those dates.This issue will be monitored through the post market product monitoring review process, standard operating procedure (sop).To date no additional information has been received.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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