MAUDE Adverse Event Report: CONVATEC DOMINICAN REPUBLIC INC L3W0750 - DUODERM; DRESSING,WOUND,OCCLUSIVE

Model Number 187660

Device Problems Delivered as Unsterile Product (1421); Unsealed Device Packaging (1444)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

(b)(6).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).

Event Description

It was reported that the package was open.The product was not used on patient.A photograph depicting the issue was received from the complainant.

Event Description

To date no additional patient or event details have been received.

Manufacturer Narrative

Correction (g1) - contact office address: (b)(6).Batch record review: lot 9e05062 was manufactured on 06/04/2019, in bodolay line, with a total of (b)(4) market units.Compliance engineer id (b)(6) performed a batch record review on 03/22/2021, to verify if all the applicable procedures were followed and no issues were found; all the components for assembly were correct per bom and all the tooling information documented was also correct, under icc code (b)(4) sap material id (b)(4).The batch record review supports that there were no discrepancies related to the issue reported.Photograph, video and/or physical sample evaluation: there are photographs associated with this case and in these, the reported defect can be seen.No unused return sample was expected.Conclusion summary of the related event: based in the analysis phase conclusions, the issue of wnd-pmc 9.6 primary pack has incomplete or open seal / weld, or is torn, ripped or contains holes or exhibits external contamination, or dressing or loose material is trapped in packaging, for products manufactured at bodolay pratt c packaging line, are attributed to the following probable causes per failure mode: for cut in seal or edge of package is cut the root causes found were: machine: indexing process variation: the indexing process variation was found as one of the major contributors to the open seal (compromised sterile barrier) due to the following opportunities: 1.Defective spindle: the spindle for film material indexation was found in bad condition, and film reel stock rotates on itself, which causes film to move inadequately and make blister to be cut in seal or dressings to be trapped in seal.2.Uncoupling of the blade¿s mechanism: there are discrepancies in the changeover of the wedge of the pulley between maintenance technicians.Even though, the position of the wedge is poka yoke, there is evidence of the usage of incorrect keyway.This affect the indexation process due to the vibrations and unpredictive movements could happen while performing the indexing process.3.Worn pulley belt and broken pulley belt teeth: there have been significant variation in the indexation process when pulley belt has been detected as defective.The machine preventive maintenance program was revised and as a result, there is not a standardized useful life for the pulley belt.4.Malfunction of servo motor: there was found an opportunity related to the automation of the bodolay machine.It was evaluated the current automation hardware of bodolay machine, and it was found that current servo motors are not able to detect sudden failures because the current automation design uses technology that are not up to date.Method: 5.Unclear steps to perform online rework: there was found an opportunity related to the standardization of the online rework performed at the line.Currently applicable pi31-142 ver.3.0 - chevron sleeve empacado automático linea bodolay, was revised and an opportunity was found regarded to the standardization of the rework perform by the operators in the two (2) point of the online rework process, currently the steps are too general or not specific.For trapped in seal or caught in seal the root causes found were: machine: indexing process variation: the indexing process variation was found as one of the major contributors to the open seal (compromised sterile barrier) due to the following opportunities: 6.Defective spindle: the spindle for film material indexation was found in bad condition, and film reel stock rotates on itself, which causes film to move inadequately and make blister to be cut in seal or dressings to be trapped in seal.7.Uncoupling of the blade¿s mechanism: there are discrepancies in the changeover of the wedge of the pulley between maintenance technicians.Even though, the position of the wedge is poka yoke, there is evidence of the usage of incorrect keyway.This affect the indexation process due to the vibrations and unpredictive movements could happen while performing the indexing process.8.Worn pulley belt and broken pulley belt teeth: there have been significant variation in the indexation process when pulley belt has been detected as defective.The machine preventive maintenance program was revised and as a result, there is not a standardized useful life for the pulley belt.9.Malfunction of servo motor: there was found an opportunity related to the automation of the bodolay machine.It was evaluated the current automation hardware of bodolay machine, and it was found that current servo motors are not able to detect sudden failures because the current automation design uses technology that are not up to date.Those failures make the indexation process to make undesired movements of the indexed materials which lead to the trapping of dressing or incorrect cut.Method: 10.Unclear steps to perform online rework: there was found an opportunity related to the standardization of the online rework performed at the line.Currently applicable pi31-142 ver.3.0 - chevron sleeve empacado automático linea bodolay, was revised and an opportunity was found regarded to the standardization of the rework perform by the operators in the two (2) point of the online rework process, currently the steps are too general or not specific.For torn or crushed the root causes found were: machine: indexing process variation: the indexing process variation was found as one of the major contributors to the open seal (compromised sterile barrier) due to the following opportunities: 11.Wrong placement of blisters: misaligned blisters do not enter properly into the market units while performing the secondary packaging process.Those blisters are torn or crushed by machine.Method: 12.Unclear steps to perform online rework.There was found an opportunity related to the standardization of the online rework performed at the line.Currently applicable pi31-142 ver.3.0 - chevron sleeve empacado automático linea bodolay, was revised and an opportunity was found regarded to the standardization of the rework perform by the operators in the two (2) point of the online rework process, currently the steps are too general or not specific.For region not sealed the root causes found were: machine: misalignment of the sealing station: the misalignment of the sealing station was found as the second major contributor for the open seal (compromised sterile barrier) affecting the regions not sealed on products packed on bodolay pratt c due to the following opportunities: 13.Incorrect height of the upper sealing tooling: there was an opportunity found related to the proper high of the upper tooling of the sealing station.Currently this height is not standardized as part of the machine set up and it is a source of variation.14.Malfunction of cylinders: during the investigation it was confirmed that cylinders in bad condition apply a wrong pressure during the sealing of paper and film.The preventive maintenance program of the machine was revised, and it was found an opportunity related to the non-standardized useful life of cylinders.15.Non-standardized use of teflon on sealing plate: current sealing tooling use teflon as a conductive of heat and to avoid paper or film to burn during the sealing of the blister.An opportunity was found because the number of layers of teflon to be used on the sealing plate has not been standardized.For extra material in seal or foreign matter the root causes found were: manpower: 16.Incorrect dressing inspection: residues of paper and film stick to dressing after elc (extrusion lamination and cutting) process, since the scrap collector is above the dressing web.Since dressings are automatically feed in the bodolay machine, the units are packaged without the operator and vision system noticing.An opportunity was found related to the inspection process performed by the elc 10 and elc 11 since dressings must be inspected 100% as per applicable pi31-103 ver 17.0 and pi31-141 ver 7.0.For dirty on package (black stain) the root causes found were: method: 17.Unclear steps to perform online rework: an opportunity was found since there is not a standardized method for the segregation and/or rework of the blisters after having a failure or breakdown on the cartoner machine.18.Wrong placement of blisters (method).During the indexation process of blisters from the primary packaging to secondary packaging, not all blisters are not organized into the counter pockets.It is a manual process.This issue causes that the blisters do not enter on the mku¿s, creating defects such as torn or crushed or dirty package.A capa plan will be generated for mitigate the root causes identified.Should additional information become available, a follow up report will be submitted.Fda registration number: reporting site: 1049092.Manufacturing site: 9618003.

• Brand Name: L3W0750 - DUODERM
• Type of Device: DRESSING,WOUND,OCCLUSIVE
• Manufacturer (Section D): CONVATEC DOMINICAN REPUBLIC INC; km 18.5 parque industrial; itabo, s.a. haina; san cristobal
• MDR Report Key: 11250358
• MDR Text Key: 229500661
• Report Number: 9618003-2021-00162
• Device Sequence Number: 1
• Product Code: NAD
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 01/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 187660
• Device Lot Number: 9E05062
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 03/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1