|
|
| Lot Number T26693 |
| Device Problems
Unintended Ejection (1234); Leak/Splash (1354); Nonstandard Device (1420)
|
| Patient Problem
Chemical Exposure (2570)
|
| Event Date 02/13/2018 |
|
Event Type
malfunction
|
|
Manufacturer Narrative
|
|
According to product quality groups: subclass: cells damaged/leaking.Return sample information:sample status: received-site.Date samples were received: 19-feb-2018.Sample evaluation: two menstrual wraps - wraps show evidence of wear.Both wraps have chemistry leaking to the outside of the wrap.Initial complaint assessment: batch t26693 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The visual inspection of retain samples included six cartons, 24 pouches and the 24 wraps inside.Inspection shows no obvious defects, to cartons, pouches or wraps.There were no cells damaged or leaking.Form-46455 retain sample inspection form documented the retain evaluation performed on 20-nov-2017 for a previous complaint.An evaluation of the complaint history confirms that this is the sixth complaint for the sub class cells damaged/leaking requiring an investigation for this batch.Three of the previous complaints (b)(4) were confirmed to have a manufacturing related root cause for the complaint of cells damaged/leaking.(b)(4) identified the root cause as equipment category, mechanical failure - the defect was caused by chemistry and brine mix being outside of the cells; thus, preventing sealing of the bottom and upper sheet.On the basis of this evaluation, a trend does not exist for this batch.An evaluation was made by searching for possible trends for this subclass requiring investigation by the site.The following pcom (pfizer global complaint database) search was performed.Scope: date contacted: 14-feb-2016 through 14-feb-2018/manufacturing site: pfizer albany/complaint class:wrap/patch/pad/ complaint sub class: cells damaged/leaking.The pcom search returned a total of 18 complaints for menstrual products during this time period for the class/subclass.Of the 18 complaints; 7 complaints have batch number recorded as ¿unknown¿.The 11 remaining complaints were evaluated.Four of.
|
| |
|
Event Description
|
|
They also went through her pants and underwear, making contact with her skin [accidental exposure to product] , black dots leaked on the floor, in the seat, on the bed, through her pants and underwear making contact with callers skin/sand was leaking from wrap [device leakage].Case narrative: this is a spontaneous report from a contactable consumer reporting for herself.A (b)(6) female patient started to receive thermacare heatwrap (thermacare menstrual), device lot number t26693, expiration date aug2020, unique identifier (b)(4), via an unspecified route of administration from an unspecified date at 1 a day, 6 hours for cramps/pelvic cramps and chronic pelvic pain.There were no concomitant medications, other medical conditions or relevant investigations.She has used thermacare menstrual wraps for 10-15 years without any issues.She used 3 boxes a month for chronic pelvic pain.She watched a (b)(6).She purchased the wraps about a week before ((b)(6) 2018).The box and the packages were properly sealed.She opened the wrap, removed the paper and applied the sticky part against her underwear.On (b)(6) 2018 after about 30 minutes of applying the patch she noticed that the dots had leaked on the floor, in the seat, on the bed.They also went through her pants and underwear, making contact with her skin.She stated there were a lot of them.The entire wrap emptied out.She was panicky because of the child being there, she was concerned about her (b)(6) getting into it.She reported it only made contact with her skin.She was scared because there were so many black dots.The wrap was open and was spilling out.She removed the wrap and has not applied another one.She was nervous about all the black dots.She vacuumed them up and was asking what she needed to watch out for.She did not know how dangerous it was.This was the second wrap she has used from the box, there were still two other wraps remaining from that box that she has not used.She used one from this current box and didn't have any issues.Then went to use a second one, but it was open on the side, one of the little pockets that has the iron it in or sand or whatever it was, the pocket wasn't sealed and it was leaking all over her apartment and furniture.She was in a lot of pain and went to use a third heatwrap from the box.She put it on, only had it on maybe 5 minutes and went to check and make sure it wasn't leaking.Explained it looked like the pocket that held the sand or iron wasn't completely sealed.It's open around one of the edges and that's where it's leaking out at.She was not hospitalized and did not receive treatment due to event black dots leaked on the floor, in the seat, on the bed, through her pants and underwear making contact with consumer's skin.The action taken for the product was permanently discontinued on 13feb2018, she immediately took it off.The outcome of the event was resolved in 2018.The consumer considered that there was no permanent impairment/damage of a body structure/function (disability)and not required medical surgical intervention to prevent permanent impairment/damage to a body function/structure (serious injury).The consumer considered it was a malfunction of device and causality of device to black dots leaked out and made contact with her skin was yes.According to product quality groups: subclass: cells damaged/leaking.Return sample information:sample status: received-site.Date samples were received: 19-feb-2018.Sample evaluation: two menstrual wraps - wraps show evidence of wear.Both wraps have chemistry leaking to the outside of the wrap.Initial complaint assessment: batch t26693 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The visual inspection of retain samples included six cartons, 24 pouches and the 24 wraps inside.Inspection shows no obvious defects, to cartons, pouches or wraps.There were no cells damaged or leaking.Form-46455 retain sample inspection form documented the retain evaluation performed on 20-nov-2017 for a previous complaint.An evaluation of the complaint history confirms that this is the sixth complaint for the sub class cells damaged/leaking requiring an investigation for this batch.Three of the previous complaints (b)(4) were confirmed to have a manufacturing related root cause for the complaint of cells damaged/leaking.(b)(4) identified the root cause as equipment category, mechanical failure - the defect was caused by chemistry and brine mix being outside of the cells; thus, preventing sealing of the bottom and upper sheet.On the basis of this evaluation, a trend does not exist for this batch.An evaluation was made by searching for possible trends for this subclass requiring investigation by the site.The following pcom (pfizer global complaint database) search was performed.Scope: date contacted: 14-feb-2016 through 14-feb-2018/manufacturing site: pfizer albany/complaint class:wrap/patch/pad/ complaint sub class: cells damaged/leaking.The pcom search returned a total of 18 complaints for menstrual products during this time period for the class/subclass.Of the 18 complaints; 7 complaints have batch number recorded as "unknown".The 11 remaining complaints were evaluated.Four of the 11 complaints were confirmed to have a manufacturing related root cause for the complaint of cells damaged/leaking.2017-01-0002203-gc, investigation 1198197 identified the root cause as method/document does not exist.There was not a manufacturing work instruction (mwi) that explains how to perform die-cutter re-adjustments during manufacturing.In addition, no procedure was identified that contains the instruction to open the cull station during die-cutter re-adjustments to ensure all produced wraps are rejected and do not move to the packaging portion of the manufacturing line.Commitment -1087812 (sop - 79534 b-line/m-line - raw material die cutter calibration mwi) was closed on 28-aug-2015 to address the die cutter calibration process.(b)(4) are all related to investigation (b)(4).(b)(4) determined the most probable root cause of the event is in the equipment category, mechanical failure.The defect was caused by chemistry and brine mix being outside of the cells; thus, preventing sealing of the bottom and upper sheet.The area appears to have been left unsealed due to the brine being in the area around the cells preventing them from sealing.This condition is something that can happen intermittently and did not continue through the entire production.If the condition persists, in-process verifications would detect and a calibration of brine dosing pumps (sop - 72378 calibration of brine dosing pumps, version 4.0, effective date: 12 sep 2017) would be performed.Review of the batch device history record for this batch concludes all release requirements were met.The review of the manufacturing attributes and variables quality checks associated with this batch indicates that all required in process inspections were performed and all inspection criteria were met.There were no wrap attribute or variable defects for the batch.Shiftly production transition notes were reviewed.There were no issues noted that would cause cells to be damaged or leaking.This batch has been reviewed from a manufacturing perspective.There were no investigations related to cells damage/leaking for this batch at the time of release.Investigation summary: the root cause category is equipment - mechanical failure; air in the brine dosing line.(b)(4) was completed for a previous confirmed cell damaged/leaking complaint for this batch.Evaluation of the wrap by technical services determined the root cause was the same for this complaint.Evaluation of the wrap shows the brine reached the edge of the cut wrap allowing for chemistry leakage outside the cell pack.Brine is delivered from the individual pumps through a manifold which then routes it through individual hoses for each cell.The hoses are connected to individual nozzles aligned with each cell.The hoses are connected to the nozzles with pressure fit couplings.The brine addition is designed to target the center of the cell.Examination of the unsealed areas of the wrap found that the defect was caused by chemistry and brine mix being outside of the cells; thus, preventing sealing of the bottom and upper sheet.The unsealed area is translucent indicating that it was not stray chemistry and it was not caused by blown cells.The area appears to have been left unsealed due to the brine being in the area around the cells preventing them from sealing.Typically air in the line presents as either a shortage of brine being dosed to the cell or when the air discharges it can tend to blow some of the chemistry and brine mix out of the cell.The most probable cause is when the cell is dosed with the brine,air in the line could splash the chemistry out of the cell preventing the top and bottom sheets sealing.This condition is something that can happen intermittent and did not continue through the entire production.If the condition persists in process verifications will detect and a calibration of brine dosing pumps (sop-72378 calibration of brine dosing pumps,version 4.0, effective date: 12-sep-2017) will be performed.There were no defects recorded during the in process quality inspections.Our manufacturing operations employ quality control procedures which include in-process testing, thermal testing and visual inspection, to ensure the quality of the product being packaged.No quality issues were identified upon this review of the batch device history record, in process attributes and variable quality checks or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.The product quality for the batch is not impacted by this complaint.Process related?: yes.Complaint confirmed?: yes.Design related?: no notify safety?: no.Capas in place?: yes.Capa reference: no capa-wraps are inspected 1 every 10 min per (b)(4) and recorded in qw; brine calibration verification is required following form 52204, menstrual c/o checklist, effect date:17 aug 2017.Follow-up (13feb2018): this follow-up report is being submitted to upgrade this case to a reportable mdr.Company clinical evaluation comment the event "black dots leaked on the floor, in the seat, on the bed, through her pants and underwear making contact with callers skin/sand was leaking from wrap" (device leakage) and accidental exposure to product were 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 events were assessed as associated with the use of the device., comment: the event "black dots leaked on the floor, in the seat, on the bed, through her pants and underwear making contact with callers skin/sand was leaking from wrap" (device leakage) and accidental exposure to product were 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 events were assessed as associated with the use of the device.
|
| |
|
Event Description
|
|
Event verbatim [preferred term].They also went through her pants and underwear, making contact with her skin/the wrap was leaking [accidental exposure to product], black dots leaked on the floor, in the seat, on the bed, through her pants and underwear making contact with callers skin/sand was leaking from wrap/the wrap was leaking [device leakage], narrative: this is a spontaneous report from a contactable consumer reporting for herself.A 34-year-old female patient started to use thermacare heatwrap (thermacare menstrual), device lot number t26693, expiration date aug2020, unique identifier (b)(4), via an unspecified route of administration from (b)(6) 2018 at 1 a day, 6 hours for cramps/pelvic cramps and chronic pelvic pain.There were no concomitant medications, other medical conditions or relevant investigations.The patient had used thermacare heatwrap (thermacare menstrual) wraps for 10-15 years without any issues.She used 3 boxes a month for chronic pelvic pain.She watched a 2 year old.She purchased the wraps about a week before ((b)(6) 2018).The box and the packages were properly sealed.She opened the wrap, removed the paper and applied the sticky part against her underwear.On (b)(6) 2018 after about 30 minutes of applying the patch she noticed that the dots had leaked on the floor, in the seat, on the bed.They also went through her pants and underwear, making contact with her skin.She stated there were a lot of them.The entire wrap emptied out.She was panicky because of the child being there, she was concerned about her two year old getting into it.She reported it only made contact with her skin.She was scared because there were so many black dots.The wrap was open and was spilling out.She removed the wrap and has not applied another one.She was nervous about all the black dots.She vacuumed them up and was asking what she needed to watch out for.She did not know how dangerous it was.This was the second wrap she has used from the box, there were still two other wraps remaining from that box that she has not used.She used one from this current box and didn't have any issues.Then went to use a second one, but it was open on the side, one of the little pockets that has the iron it in or sand or whatever it was, the pocket wasn't sealed and it was leaking all over her apartment and furniture.She was in a lot of pain and went to use a third heatwrap from the box.She put it on, only had it on maybe 5 minutes and went to check and make sure it wasn't leaking.She discovered it had a little hole in it as well.Not quite like the other one, but it was leaking too.The patient explained it looked like the pocket that held the sand or iron wasn't completely sealed.It's open around one of the edges and that's where it's leaking out at.She was not hospitalized and did not receive treatment due to events.Black dots leaked on the floor, in the seat, on the bed, through her pants and underwear making contact with her skin.The action taken for the product was permanently discontinued on (b)(6) 2018, she immediately took it off.The outcome of the events was resolved in 2018.The consumer considered that there was no permanent impairment/damage of a body structure/function (disability)and not required medical surgical intervention to prevent permanent impairment/damage to a body function/structure (serious injury).The consumer considered it was a malfunction of device and causality of device to black dots leaked out and made contact with her skin was yes.According to product quality groups on (b)(6) 2018: subclass: cells damaged/leaking.Return sample information: sample status: received-site.Date samples were received: 19-feb-2018.Sample evaluation: two menstrual wraps - wraps show evidence of wear.Both wraps have chemistry leaking to the outside of the wrap.The root cause for this investigation was revised per investigation (b)(4) menstrual & muscle joint us cells damaged/leaking.And to complete action item (b)(4): identify & update all previous complaint investigations due to unsealed cells for the four batches.The market action was also added.The root cause of this event is brine was placed outside the cells during manufacturing due to an unseated supply line allowing air into the system.This could happen after purging if the supply line from the connector to the dispensing plate was left unseated as it was removed from the brine purge box and placed back onto the brine carriage.Method was considered as a contributory factor because an mwi for purging brine is necessary.There is no document that clearly provides instructions on how to purge brine.The root cause category is equipment/other with method as a contributory factor.This created a scenario where a small amount of air could enter the supply line and this air discharged as the line ran at the slower steady state of the slower variable speed of 100 wraps per minute (wpm); then, the brine sputtered as the air bubble discharged from the brine nozzle, placing the brine outside of the cell area.Because the brine is injected slightly forward during slower speeds, this brine outside of the cell rolled upstream due to the motion of the platens as they travel forward in the machine direction.This liquid (brine) travelled upstream, covering the surface of the bottom film and the dosed pre mix powder for multiple cells of the wrap.This brine outside of the cell was captured between the hpm films preventing the top and bottom film layers from being bonded by the seal roll.Due to the perimeter of the cell area not being bonded (layer of two films), it allowed the pre mix powder to flow outside of the cell area.Our manufacturing operations employ quality control procedures which include in process testing, and visual inspection, to ensure the quality of the product being packaged.No quality issues were identified upon this review of batch records, release testing data or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.Investigation (b)(4) menstrual & muscle joint us cells damaged/leaking was conducted for the same sub-class.This batch t26693 was reviewed at aqrt and the outcome determination was to recall the four batches (t26691, t26693, and t26686 & s68516) per investigation (b)(4).Capas in place?: yes.Date of capa implementation: (b)(6) 2018.Capa reference: 2424148-mwi for purging brine,2424164-brine manifold supply line connectors,2424171-hpm hourly inspection,2424184-need to increase border of the wrap,2424195-brine solution detectability,2424199- update fmea rpt-39239,2424234-revise investigation.Follow-up (13feb2018): this follow-up report is being submitted to upgrade this case to a reportable mdr.Follow-up (16apr2020): this is a follow-up report combining information from duplicate reports 2018070438 and 2018068668.The current and all subsequent information will be reported under manufacturer report number 2018068668.The new information reported from the product quality complaint group includes updated investigational results on 15oct2018.Follow-up attempts are completed.No further information is expected., comment: the event "black dots leaked on the floor, in the seat, on the bed, through her pants and underwear making contact with callers skin/sand was leaking from wrap" (device leakage) and accidental exposure to product were 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 events were assessed as associated with the use of the device.Company conducted an investigation, the most probable root cause for this event was classified.There is no trend identified for the subject batch for cell pack leakage.No market action was recommended.Company conducted an investigation, and the most probable root cause for this event was classified, capa was implemented, and no further action is recommended.
|
| |
|
Manufacturer Narrative
|
|
According to product quality groups: subclass: cells damaged/leaking.Return sample information:sample status: received-site.Date samples were received: 19-feb-2018.Sample evaluation: two menstrual wraps - wraps show evidence of wear.Both wraps have chemistry leaking to the outside of the wrap.Initial complaint assessment: batch t26693 is the only batch within the scope of this investigation.Thermacare batches are produced as individual lots.The visual inspection of retain samples included six cartons, 24 pouches and the 24 wraps inside.Inspection shows no obvious defects, to cartons, pouches or wraps.There were no cells damaged or leaking.Form-46455 retain sample inspection form documented the retain evaluation performed on 20-nov-2017 for a previous complaint.An evaluation of the complaint history confirms that this is the sixth complaint for the sub class cells damaged/leaking requiring an investigation for this batch.Three of the previous complaints (b)(4)) were confirmed to have a manufacturing related root cause for the complaint of cells damaged/leaking.(b)(4) identified the root cause as equipment category, mechanical failure - the defect was caused by chemistry and brine mix being outside of the cells; thus, preventing sealing of the bottom and upper sheet.On the basis of this evaluation, a trend does not exist for this batch.An evaluation was made by searching for possible trends for this subclass requiring investigation by the site.The following pcom (pfizer global complaint database) search was performed.Scope: date contacted: 14-feb-2016 through 14-feb-2018/manufacturing site: pfizer albany/complaint class:wrap/patch/pad/ complaint sub class: cells damaged/leaking.The pcom search returned a total of 18 complaints for menstrual products during this time period for the class/subclass.Of the 18 complaints; 7 complaints have batch number recorded as ¿unknown¿.The 11 remaining complaints were evaluated.Four of the 11 complaints were confirmed to have a manufacturing related root cause for the complaint of cells damaged/leaking.(b)(4), investigation 1198197 identified the root cause as method/document does not exist.There was not a manufacturing work instruction (mwi) that explains how to perform die-cutter re-adjustments during manufacturing.In addition, no procedure was identified that contains the instruction to open the cull station during die-cutter re-adjustments to ensure all produced wraps are rejected and do not move to the packaging portion of the manufacturing line.Commitment ¿ 1087812 (sop - 79534 b-line/m-line - raw material die cutter calibration mwi) was closed on 28-aug-2015 to address the die cutter calibration process.2017-11-0071835-us (b)(4)), 2017-12-0076078-us (b)(4)) and 2018-01-0006439-us (b)(4)) are all related to investigation (b)(4).(b)(4) determined the most probable root cause of the event is in the equipment category, mechanical failure.The defect was caused by chemistry and brine mix being outside of the cells; thus, preventing sealing of the bottom and upper sheet.The area appears to have been left unsealed due to the brine being in the area around the cells preventing them from sealing.This condition is something that can happen intermittently and did not continue through the entire production.If the condition persists, in-process verifications would detect and a calibration of brine dosing pumps (sop ¿ 72378 calibration of brine dosing pumps, version 4.0, effective date: 12 sep 2017) would be performed.Review of the batch device history record for this batch concludes all release requirements were met.The review of the manufacturing attributes and variables quality checks associated with this batch indicates that all required in process inspections were performed and all inspection criteria were met.There were no wrap attribute or variable defects for the batch.Shiftly production transition notes were reviewed.There were no issues noted that would cause cells to be damaged or leaking.This batch has been reviewed from a manufacturing perspective.There were no investigations related to cells damage/leaking for this batch at the time of release.Investigation summary: the root cause category is equipment - mechanical failure; air in the brine dosing line.(b)(4) was completed for a previous confirmed cell damaged/leaking complaint for this batch.Evaluation of the wrap by technical services determined the root cause was the same for this complaint.Evaluation of the wrap shows the brine reached the edge of the cut wrap allowing for chemistry leakage outside the cell pack.Brine is delivered from the individual pumps through a manifold which then routes it through individual hoses for each cell.The hoses are connected to individual nozzles aligned with each cell.The hoses are connected to the nozzles with pressure fit couplings.The brine addition is designed to target the center of the cell.Examination of the unsealed areas of the wrap found that the defect was caused by chemistry and brine mix being outside of the cells; thus, preventing sealing of the bottom and upper sheet.The unsealed area is translucent indicating that it was not stray chemistry and it was not caused by blown cells.The area appears to have been left unsealed due to the brine being in the area around the cells preventing them from sealing.Typically air in the line presents as either a shortage of brine being dosed to the cell or when the air discharges it can tend to blow some of the chemistry and brine mix out of the cell.The most probable cause is when the cell is dosed with the brine,air in the line could splash the chemistry out of the cell preventing the top and bottom sheets sealing.This condition is something that can happen intermittent and did not continue through the entire production.If the condition persists in process verifications will detect and a calibration of brine dosing pumps (sop¿72378 calibration of brine dosing pumps,version 4.0, effective date: 12-sep-2017) will be performed.There were no defects recorded during the in process quality inspections.Our manufacturing operations employ quality control procedures which include in-process testing, thermal testing and visual inspection, to ensure the quality of the product being packaged.No quality issues were identified upon this review of the batch device history record, in process attributes and variable quality checks or, inspection of retained samples.Retained samples met the product description and the product is within expiration date.The product quality for the batch is not impacted by this complaint.Process related?: yes.Complaint confirmed?: yes.Design related?: no notify safety?: no.Capas in place?: yes.Capa reference: no capa-wraps are inspected 1 every 10 min per spec-22609 and lab-19998 and recorded in qw; brine calibration verification is required following form 52204, menstrual c/o checklist, effect date:17 aug 2017.
|
| |
|
Search Alerts/Recalls
|
|
|
