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As for 30apr2018, the investigational result included: the most probable root cause of this event is method/other.Non-woven manufacturing process generates buildups when the materials are conveyed throughout the production lines.There are areas more susceptible to accumulate buildups due to the movements of the web during its transition.The cleaning of these areas is considered critical to keep the control of the web through the manufacturing process to avoid web mistracking issues.During this incident, the accumulation of glue (buildup) on dead plates repositioned the web cells in the cross machine direction (mistracking).Therefore, the cells were placed in a different position of the profiled edge exposing the cells to be in direct contact with the die cutter blade.This jeopardized the seal of the perimeter of the cells and allowed the premix to leak from the cut edge of the product.Sop-# "equipment cleaning, inspection and lubrication (cil) procedure" includes instructions to clean the m-line critical areas in each production shift.The sop-# version effective during the manufacturing of batch t26693 was 4.0 (effective date 25apr2016).In this sop-# version, the critical cils can be performed any time during the each manufacturing shift.Sop-# was revised as part of continuous improvement after the manufacturing of batch t26693.In the current version of sop-#, the critical cils were highlighted in yellow and now they have priority to be performed first during each manufacturing shift.The hpm dead plates are included in the critical category.The m-line has a camera system for wraps inspection.This is the line mitigation tool to detect defective wraps and eject them from the line.Cameras 3 & 4 perform 100% inspections (take picture) of the wraps after the wraps are die-cut into discreet products to determine cut cells or if the cells are too close to the edge of the wrap (less than 3 mm).If the wrap was cut with the edge too close to the cell (less t).
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Event verbatim (preferred term) side of wrap split open/the black particle contents inside have come in contact with her skin (accidental exposure to product), side of wrap split open/the black particle contents inside have come in contact with her skin (device leakage).Case narrative: the initial case was missing the following minimum criteria: specify criteria: no adverse event.Upon receipt of follow-up information on 16oct2018, this case now contains all required information to be considered valid.This is a spontaneous report from a contactable consumer.A (b)(6) year-old female patient started to receive thermacare heatwrap (thermacare menstrual), device lot number t26693 , expiration date aug2020, from an unspecified date at unknown frequency for menstrual pain.Medical history was none.There were no concomitant medications.The patient was using the thermacare for menstrual pain, and the side had split open on (b)(6) 2018.The black particle contents inside had come in contact with her skin on (b)(6) 2018.She felt fine, but the box said for her to seek medical help right away.She did notice that the heat cells were off center, like it had been cut wrong.Some were really close to the edge of the wrap.The sample of the product was available to be returned.The action taken in response to the events was unknown.The outcome of the events was unknown.As for 30apr2018, the investigational result included: the most probable root cause of this event is method/other.Non-woven manufacturing process generates buildups when the materials are conveyed throughout the production lines.There are areas more susceptible to accumulate buildups due to the movements of the web during its transition.The cleaning of these areas is considered critical to keep the control of the web through the manufacturing process to avoid web mistracking issues.During this incident, the accumulation of glue (buildup) on dead plates repositioned the web cells in the cross machine direction (mistracking).Therefore, the cells were placed in a different position of the profiled edge exposing the cells to be in direct contact with the die cutter blade.This jeopardized the seal of the perimeter of the cells and allowed the premix to leak from the cut edge of the product.Sop-# "equipment cleaning, inspection and lubrication (cil) procedure" includes instructions to clean the m-line critical areas in each production shift.The sop-# version effective during the manufacturing of batch t26693 was 4.0 (effective date 25apr2016).In this sop-# version, the critical cils can be performed any time during the each manufacturing shift.Sop-# was revised as part of continuous improvement after the manufacturing of batch t26693.In the current version of sop-#, the critical cils were highlighted in yellow and now they have priority to be performed first during each manufacturing shift.The hpm dead plates are included in the critical category.The m-line has a camera system for wraps inspection.This is the line mitigation tool to detect defective wraps and eject them from the line.Cameras 3 & 4 perform 100% inspections (take picture) of the wraps after the wraps are die-cut into discreet products to determine cut cells or if the cells are too close to the edge of the wrap (less than 3 mm).If the wrap was cut with the edge too close to the cell (less than 3 mm) or it has a cut cell the wrap is ejected from the line.When a defective wrap is detected by the cameras its position is recorded by the plc system.Then, the wrap is conveyed throughout the product folding area.Once the product is folded it is conveyed to the reject station.The defective wrap identified by the cameras is diverged from the line by a compressed air pneumatic nozzle.The position of the wrap over the conveyor is critical to be ejected from the line when it conveyed from the camera station to the eject point.During a mistracking issue, the position of product conveyed on the line could be changed because the line is susceptible to have jams and many stops and restarts (process variation).Therefore, if the positon of the defective wrap is change from the point of the camera station to the eject system an incorrect wrap could be ejected from the line.This is most probable cause of why the defective wrap under this investigation was not ejected from the line.During the manufacturing of batch t26693 approximately (b)(4) wraps were ejected from the line (camera 3 = 8,967 & camera 4 = 9,284).Cameras 3 & 4 rejected those wraps because they have cut cells or the wraps did not comply with the 3mm distance from the edge of the wrap to edge of the cells.In addition, all cameras reject verification checks performed during batch t26693 complied with the criteria (correct wrap identified and correct wrap ejected from the line).Therefore, the camera system was working as expected.Training can be ruled out.The production operators and contingent employees involved in the heat pack maker process have been trained.Equipment can be ruled out because it is not related to the mistrack issue.Measurement can be ruled out.There is no measurement system related to this event.Material can be ruled out because it is not related to the mistrack issue.Environment was ruled as the root cause because a cut cells defect is not related to the environment conditions.Corrective actions: there is no market action recommended.Batch t26693 met all product release criteria and it will remain in release status.There are specific product use instructions on the carton, pouch film and insert stating, "do not use if the heat cell contents leak and/or wrap is damaged or torn".This investigation recommends no further actions to be taken for batch t26693.Preventive actions: there is no preventive action.Sop-# "equipment cleaning, inspection and lubrication (cil) procedure" includes instructions to clean the line critical areas in each production shift.The sop-# version effective during the manufacturing of batch t26693 was 4.0 (effective date 25apr2016).In this sop-# version, the critical cils can be performed any time during the each manufacturing shift.Sop-# was revised as part of continuous improvement after the manufacturing of batch t26693.In the current version of sop-#, the critical cils were highlighted in yellow and now they have priority to be performed first during each manufacturing shift.The hpm dead plates are included in the critical category.This is going to mitigate the mistracking caused by the glue buildup in the hpm dead plates.Batch t26693 remains in release status.As for 16oct2018, the investigational results included: this complaint investigation was reopened due to edits to investigation (b)(4) root cause in the initial assessment.The conclusion.Qa summary and market action will also be updated per investigation (b)(4) - t26691, t26693, t26686 & s68516 menstrual & muscle joint us cells damaged/leaking.The revision requires qa manager and sqol approval.On (b)(6) 2018 by (name) (qa specialist).Quality impact: process related: yes; a market action to recall batch t26693 resulted from aqrt for an unrelated root cause and investigation (b)(4) "t26691, t26693, t26686 & s68516 menstrual & muscle joint us cells damaged/leaking".The root cause of (b)(4) is not related to cut cell but rather to brine placed outside the cells during manufacturing due to an unseated supply line allowing air into the system.This prevented the top and bottom sheets to seal creating the chemistry leakage.Company clinical evaluation comment: the above referenced lot number t26693 was recalled on 02oct2018.Subsequent to the conclusion of a manufacturing investigation, pfizer initiated a voluntary recall of 6 lots (s68516, t26686, t26691, t26693, 8054ha, 8054hb) due to a potential for device leakage of the ingredients contained in the heat wrap that could result in serious skin-related events, including burn.These 6 lots were distributed in the united states with expiry dates of either july or august 2020., comment: the above referenced lot number t26693 was recalled on 02oct2018.Subsequent to the conclusion of a manufacturing investigation, pfizer initiated a voluntary recall of 6 lots (s68516, t26686, t26691, t26693, 8054ha, 8054hb) due to a potential for device leakage of the ingredients contained in the heat wrap that could result in serious skin-related events, including burn.These 6 lots were distributed in the united states with expiry dates of either july or august 2020.
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