Device 1 of 1.(b)(6).Distributor: (b)(4) 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.(b)(4).
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Correction (g1) - contact office address: (b)(4).This complaint is associated with related event tw (b)(4) and will remain open until the investigation associated with related event tw (b)(4) is complete.Photograph and samples have been received for this complaint, where is visible damage of primary pack.Batch record review was conducted resulting in following: uno drain fix s (25/200)ster int in question was manufactured under sap material id: 1301277, ref: (b)(4), and manufacturing lots # 0c02508.The securement were produced, visually checked under subassembly lots 0a06095 from 07th of february 2020 till 22nd of february 2020 and 0b02763 from 21st of february 2020 till 05th of march 2020 on manual operation station c080 and then packed into the peelpacks (pouch) under lot 0c02508 from 24th of march 2020 till 26th of march 2020 on center c2 on machine p013, with total lot amount (b)(4) pcs.Lot # 0c02508 was sterilized under certificate 2173-9965a and released based on the review of results of sterilization provided by sterilization company steris.All the results were within specification and products were released in compliance with sop-000801.Review of the dhr showed that all relevant tests required during the manufacturing process and final product release had been fulfilled and met the requirements.The process parameters were adjusted within the validated window.The packaging of products was run according to the process instruction pi41-013 for packing of sterile securements products and recorded in br41-013.No nonconformance has been registered during the manufacturing process of the affected lots and of the mention malfunction code¿ sec-pmc07.06 primary pack (sterile products) has incomplete or open seal / weld, or is torn, ripped or contains holes or exhibits external contamination (e.G.Water marks, stains), or securement or loose material is trapped in packaging¿.One other complaint was registered on the lot 0c02508 and malfunction code (tw (b)(4) - package is open), but issue is different and will be investigated within separated event tw(b)(4).Incoming material used during production of lot 0c02508 was checked.It was used packing paper ppr gas uno drn-fix 415mm ¿ sap code 1256437g3, lots 0001316291 and 0001442544.Incoming inspection for material 1256437g3 with batch numbers 0001316291 and 0001442544 were in accordance with material specification mt50-017.Materials were released based on control of certificates.Certificates were reviewed and they were in accordance with mt50-017.This complaint is within scope of investigation event tw#(b)(4) - package broken securement (uno drain fix s 25/200 ster int).The most probable root cause resulted from the investigation ir21-005-mic (ver.1) were identified: rc1: neglect of the operator.Rc2: control of cutting knives is not included in process instruction.Rc3: pre-printed printing on paper floats to the sides of the paper.Rc4: inattention of the operators.Investigation report ir 21-005-mic (ver.1) / tw (b)(4) was approved at crb-c5/qa/wh-mic held on 26-apr-2021 by meeting attendants.Based on the investigation results the issue is considered to be isolated.Capa will be open.The investigation associated with related event tw (b)(4) 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.Fda registration number reporting site: 1049092.Manufacturing site: 3005778470.
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