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Root cause analysis/identify.: the most probable root cause of this event is equipment / mechanical failure equipment (rule-in) the non-woven materials that are stack-up over the cell pack of the thermacare menstrual product are glued by the m-line gawas (glue assembly web assembly) identified as 0-2 and 1-1.The gawas head glue applicators and its modules/nozzles are responsible to spray glue over the menstrual product cell pack to bond the hec at the body side and the sca on the clothing side.The gawa 0-2 sprays glue to for the hec bonding and gawa 1-1 for the sca bonding.The returned sample shows glue blobs on the body side (hec).It was determined by technical services and manufacturing members that these glue blobs came from gawa 0-2.It was reported in the manufacturing shiftly notes of batch t78909 issues with the nozzles of gawa 0-2.Blockage or defective nozzles affect the glue spaying and can create glue blobs when the glue is dripping over the product.It was observed on the returned sample a wide band of glue over the cell pack which confirms the problem with the glue pattern.Three nozzles were changed due to poor glue coverage.The issue was resolved and no more issues related to the gawas were reported.This is the most probable cause of this incident.The preventive maintenance (pm) for the gawas (gawa00o6-pm gawa monthly check) was reviewed.There are instructions for nozzle and glue system inspection in a monthly basis.No changes are proposed for this pm.The glue nozzles require cleaning with wax bars to maintain the appropriate glue pattern.Sop-63921 "equipment cleaning, inspection and lubrication (cil) procedure" includes instructions to clean the m-line critical areas in each production shift and on an ongoing, as needed basis during the shift to ensure line runs effectively and produces good quality product.It includes the gawas.The sop-63921 version effective during the manufacturing of batch t78909 was 5.0 (effective date 28sep2017).In.
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Event verbatim [preferred term] it looked like the contents were out of the little oval heat cell /the contents of the heat cells were contained with the wrap and not on the outside [device leakage] ,.Case narrative: this is a spontaneous report from a contactable consumer.This female consumer of unknown age started to receive thermacare heatwrap (thermacare menstrual) lot number t78909, expiration date nov2020, udi number (b)(4), via an unspecified route of administration from an unspecified date to an unspecified date at unknown dose for an unspecified indication.Medical history and concomitant medications were not reported.The patient thought there was a problem with the thermacare menstrual heatwraps she purchased.She reported that it looked like the contents were out of the little oval heat cell.As of (b)(6)2018, she stated that when she opened the foil pouch she noticed the contents of the heat cells were not in the fabric but were loose in the pouch (pending clarification).As of (b)(6) 2018, she further stated when she opened the pouch the contents of the heat cells were contained with the wrap and not on the outside.She never wore the heat wrap.The action taken in response to the event of the product was unknown.The outcome of the event was unknown.Additional information received from product quality complaint (pqc) group included investigation results.Root cause analysis/identify.: the most probable root cause of this event is equipment / mechanical failure equipment (rule-in) the non-woven materials that are stack-up over the cell pack of the thermacare menstrual product are glued by the m-line gawas (glue assembly web assembly) identified as 0-2 and 1-1.The gawas head glue applicators and its modules/nozzles are responsible to spray glue over the menstrual product cell pack to bond the hec at the body side and the sca on the clothing side.The gawa 0-2 sprays glue to for the hec bonding and gawa 1-1 for the sca bonding.The returned sample shows glue blobs on the body side (hec).It was determined by technical services and manufacturing members that these glue blobs came from gawa 0-2.It was reported in the manufacturing shiftly notes of batch t78909 issues with the nozzles of gawa 0-2.Blockage or defective nozzles affect the glue spaying and can create glue blobs when the glue is dripping over the product.It was observed on the returned sample a wide band of glue over the cell pack which confirms the problem with the glue pattern.Three nozzles were changed due to poor glue coverage.The issue was resolved and no more issues related to the gawas were reported.This is the most probable cause of this incident.The preventive maintenance (pm) for the gawas (gawa00o6-pm gawa monthly check) was reviewed.There are instructions for nozzle and glue system inspection in a monthly basis.No changes are proposed for this pm.The glue nozzles require cleaning with wax bars to maintain the appropriate glue pattern.Sop-63921 "equipment cleaning, inspection and lubrication (cil) procedure" includes instructions to clean the m-line critical areas in each production shift and on an ongoing, as needed basis during the shift to ensure line runs effectively and produces good quality product.It includes the gawas.The sop-63921 version effective during the manufacturing of batch t78909 was 5.0 (effective date 28sep2017).In this sop-63921 version, the critical cils can be performed also any time during each manufacturing shift.Sop-63921 was revised as part of continuous improvement after the manufacturing of batch t78909.In the current version of sop-63921 v9.0, effective date 28sep2018 the critical cils were highlighted in yellow and now they have priority to be performed first during each manufacturing shift.The gawas are included in the critical category.No changes are proposed for this procedure.There is an in-process quality inspection performed during production of finished product batches.The attribute inspection for major glue blobs/drips is a visual inspection of the wrap and it was conducted for batch t78909 every 10 minutes of uptime per spec-22087 "therapeutic heat wrap/lower abdomen/ thermacare menstrual ii, wh-1410-0006 v.11.0 effective date28nov2016.The review of the manufacturing attributes and variables inspections associated to batch t78909 indicates that all required in-process inspections were performed and all inspections criteria were met.There were no wrap attribute or variable defects recorded for batch t78909.Therefore, this incident is considered an isolated event.The current version of menstrual formula card spec-22087 was modified and the attribute inspection for major glue blobs/drips is performed more often (every 6 minutes).Sop-80350 "thermacare product attribute measurement" v1.0, effective date: 31jan2018 was created after the manufacturing of batch t78909.This procedure includes specific instructions of how to perform the different attribute checks.It includes instructions to identify and classify glue blobs according its appearance and size.Also, it describes how to identify gap or issues in the glue pattern.This procedure was created as standardized method to identify and classify defects in the product attribute.Therefore, the manufacturing technicians now are able to identify the glue blobs defects in a standardized way.Training can be ruled out.The production operators and contingent employees involved in the heat pack maker process have been trained.Method can be ruled out.Sop-63921 "equipment cleaning, inspection and lubrication (cil) procedure" includes instructions to clean the m-line critical areas in each production shift.It includes the m-line gawas cleaning procedure.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 glue blobs issue.Environment was ruled as the root cause because the glue blobs defect is not related to the environment conditions.Corrective actions: there is no market action recommended.Batch t78909 met all product release criteria and it will remain in release status.The defective nozzles were replaced and the issue was resolve.This incident is considered an isolated event.This investigation recommends no further actions to be taken for batch t78909.Preventive actions: there is no preventive action.There are controls in place to detect and manage the glue blob defects: the gawas preventive maintenance includes a monthly inspection of the glue heads.The menstrual product formula card spec-22087 was modified after the manufacturing of batch t78909 to conduct the product attribute inspection for glue blobs most often (every 6 minutes) instead of every 10 minutes.Sop-63921 contains instructions to clean the line critical areas in each production shift including the gawas.Sop-80350 was created after the manufacturing of batch t78909.This procedure was created as standardized method to identify and classify defects for product attributes.Now, the manufacturing technicians are able to identify the glue blobs defects in a standardized way.Conclusion: the most probable root causes for this event is equipment / mechanical failure.The defective glue nozzles affected the glue spraying pattern and could create the glue blobs observed in the return samples.It was reported in the manufacturing shiftly notes of batch t78909 issues with the nozzles of gawa 0-2.Blockage or defective nozzles affect the glue spaying and can create glue blobs when the glue is dripping over the product.It was observed on the returned sample a wide band of glue over the cell pack which confirms the problem with the glue pattern.The issue was resolved and no more issues related to the gawas were reported.This is the most probable cause of this incident.There are controls in place to detect the glue blobs on the product.Glue blobs over the cell pack could decrease the temperature of the wrap (cold wrap).There is no impact to the safety of the patient since there were no damaged cells for this event.No market action was recommended because batch t78909 met all product release criteria and it will remain in release status.Batch t78909 remains in release status.Follow-up (19sep2018): this follow-up report is being submitted to upgrade this case to a reportable mdr.Company clinical evaluation comment the event "it looked like the contents were out of the little oval heat cell/when she opened the foil pouch she noticed the contents of the heat cells were not in the fabric but were loose in the pouch " (device leakage) was assessed as non-serious.No other adverse event was associated with the use of the device.This is a single potential device malfunction has a theoretical risk to cause skin burn.The event was assessed as associated with the use of the device., comment: the event "it looked like the contents were out of the little oval heat cell/when she opened the foil pouch she noticed the contents of the heat cells were not in the fabric but were loose in the pouch " (device leakage) was assessed as non-serious.No other adverse event was associated with the use of the device.This is a single potential device malfunction has a theoretical risk to cause skin burn.The event was assessed as associated with the use of the device.
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