The device history record (dhr) was not performed during this investigation as the lot number was not received with the complaint.All dhr¿s are reviewed and approved by quality prior to the release of the product.A sample has not been received for analysis.Without a sample we are unable to perform a thorough follow up investigation to include functional and visual evaluation to determine the root cause(s) of the reported condition or implement any corrective action(s).While a definitive root cause could not be determined without a returned sample, a likely contributor for this issue is as the vertical sealer bar is sealing the top of two consecutive pouches, there could be a localized weak region just prior to the midpoint of the vertical sealer bar causing an incomplete seal.Additionally, there could have been some type of buildup on the sealer bars that would cause a localized weak spot.Relative to the issue reported by the customer, pressure was applied by the clinician and this area of the pouch broke open.The results of the manufacturing facility investigation were able to identify a localized area of the pouch that was the likely area where the pouch contents leaked out of.A review of maintenance activity noted that the sealer bars were dirty and worn and were therefore cleaned and replaced.The operator¿s preventive maintenance (pm) guide has been updated to include a visual inspection and cleaning of all sealer bars and dies every month during regular pm¿s.
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