Samples received: 9 unopened, unused, sterilizing sachets are received.Preliminary analysis: stock review: we proceed to review the stock of this product code and lot number and verifies that to date there are no available units.Quantity produced / imported: a total of 6,000 units of the reported batch were manufactured.Background: the claims database was reviewed and it was confirmed that there is no report related to this product code and lot number.Batch record: the documentation corresponding to the production of the batch was reviewed and it was verified that the batch had a normal process, no deviations or alterations were identified during production.Analysis of the sample (s): the samples received were visually inspected and it was possible to identify that the nine units were without the sterilizing solution; this was caused by an anomaly in the manufacturing process, which is not detectable in the final control and affects a minimum percentage of the lots; for this defect a corrective action was created (2016-ac-012).In relation to the disassembly, it is not possible to perform an analysis with the samples received since they have no liquid and this causes the product conditions to change.We take as reference the data in relation to the strength of the assembly made for the batch release and the results obtained comply with the usp and the requirements of b.Braun.Results: average: 1.29 kgf., minimum: 0.76 kgf.(reference value usp average 0.68 kgf).Conclusions: actions: no action is required, since the fault that caused the cause reported in the claim was corrected long before receiving this report.
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