Initial reporter: (b)(6).Based on the available information, this event is deemed to be a reportable malfunction.Additional information has been requested, however to date no additional information has been received.Should additional information become available, a follow-up report will be submitted.
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An investigation was completed for this complaint by the assigned manufacturing site investigation team.The complaint summary of this investigation required rework.A corrective actions/preventive actions (capa) was raised, and an updated/corrected investigation summary has been completed in accordance with assigned capa.A supplemental mdr is being submitted to document the completion of investigation rework and final investigation; the complaint record will proceed to closure.Batch record review: lot 8c02063 was manufactured on 03/23/2018 in the convex 1-piece (pc) line with a total of (b)(4) market units.Complaint investigator performed a batch record review on 05/18/2019 to verify if all the applicable procedures were followed and no issues were found; all the components for assembly were correct per bill of materials (bom) and all the tooling information documented was also correct, under international commodity code (icc) code 175779 system application product (sap) material identification (id) 1000620 and manufacturing order (b)(4).The batch record review supports that there were no discrepancies related to the issue reported.Returned sample evaluation: photographs were associated with this case and no unused return sample was expected.Conclusion summary of the related event: based in the investigation findings, the root cause identified for the issue ¿wafer off center in the pouch¿, reported under failure mode ¿skin barrier starter hole is defective (e.G.Misalignment or off center), leakage may occur¿ is attributed to: 1) machine: the investigative process concluded that all the machinery/ tooling items used in the manufacturing process complied when compared against drawing and process instructions (pi) specifications; however, as part of this investigation on 10/may/2019, maintenance and facilities manager and senior process engineer performed a deep assessment to the sub-assembly station of the convex 1-piece (pc) machine identifying the conditions causing the wafer off center and the possible solutions to correct the failure.As conclusion of the assessment, the chain that coordinates flange loading station with adhesive loading station needed lubrication and the chain and other components of the mechanism needed a corrective maintenance.In order to maintain this condition in the long term, a deeper intervention of the mechanism is required.Furthermore, regarding the rotary table station of the convex 1-piece (pc) machine, it was identified that due to the demands of the process, the tooling used to manufacture the urodress product family require a redesign modification to reduce the variability within the manufacturing process.As a contributor factors the following opportunities for improvements were identified: 2) process / method investigation: a) reference in the process instructions (pi), the applicable quality control (qc) tooling used for product¿s quality inspection purpose of pouch uro 177a products family in order to address manufacturing personnel the use of them.B) identification of the defect during the manufacturing process, it should be considered the implementation of a job aid for product centralization out of specification.3) process / method / measurement investigation: a) introduce quality control (qc) tooling used for product¿s quality inspection purpose in the calibration program to guarantee measurement assurance.4) manpower: a) there are not manpower causes associated with the root cause; even though, opportunity to improve the loading of the adhesive disc during the manufacturing process was identified by implementing a standard work instruction for convex 1-piece (pc) to indicate manufacturing operators how to properly load the adhesive disc.No issues were identified for material and environment investigations.The investigation associated with related event has been approved and is complete.No additional action is required, and this complaint will be closed.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.Reporting site: 1049092.Manufacturing site: 9618003.
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