E1: (b)(6).Based on the available information, this event is deemed to be a reportable malfunction.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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Additional information - this emdr is being submitted to include the below: h6 - investigation results under imdrf cause investigation code, imdrf investigation findings, imdrf cause conclusions.H10: investigation summary: a batch record review was completed and no discrepancies were found.All seal integrity tests completed throughout the batch manufacture were satisfactory.Kaltostat wnd pkg 2g wt (1x5pk) ster int was manufactured under system application product (sap) code (b)(4) and manufacturing lot number 3c04741 on (b)(6) 2023.This date is reflected as the start date for the batch within the batch record, but system application product (sap) identifies the batch was manufactured 21 march 2023.Lot # 3c04741 was sterilized under (b)(4) 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 3c04741.This is the only complaint for the affected lot registered within database.Two photographs were received for this issue and have been evaluated in accordance with work instructions (wi).The photographs confirm the product, lot and expected complaint issue where an open seal can be seen in a primary sachet.The complaint sample was requested on(b)(6) 2024, but was not received within 30 days or before the complaint needed to be closed.An non-conformance (nc) record was opened and escalated to a corrective action / preventive actions (capa) in relation to kaltostat out of specification rope product causing open seals or incomplete seals in the primary pack as the kaltostat rope was too thick.From the non-conformance (nc) investigation, the assignable root cause was that the autoleveller used to control weights for the machine that manufactures the raw rope product at rhymney is at the end of its life due to machine parts being obsolete.Investigation continues to identify how this can be addressed to prevent recurrence.A planned deviation is in place for running the machine until improvement actions can be implemented.This issue will be monitored through the post market product monitoring review process.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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