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

Model Number 187957

Device Problems Delivered as Unsterile Product (1421); Contamination /Decontamination Problem (2895); Device Contaminated During Manufacture or Shipping (2969)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

It was reported that there was foreign body found inside the package.The product was not used.Photographs depicting the issue were received from the complainant.

Manufacturer Narrative

(b)(6).(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).

Manufacturer Narrative

Additional information - this emdr is being submitted to include the below: h6 - investigation results under imdrf cause investigation code, imdrf investigation findings, imdrf cause conclusions h10: investigation summary: correction (g1) - contact office address: (b)(6).Batch record review: lot 1c01608 was manufactured on 03/12/2021 in the bodolay line with a total of 10,800 market units.Complaint investigator id 5173 performed a batch record review on (b)(6) 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, sap material id 1704769 and manufacturing order 1570769.The batch record review supports that there were no discrepancies related to the issue reported.Returned sample evaluation: photo related to the reported problem was available for evaluation.Investigation summary: based in the analysis phase conclusions.Root cause(s) / issue to be addressed: based in the analysis phase conclusions, the issue 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 rotated on itself, which caused film to move inadequately and made the blister to be cut in seal or dressings to be trapped in seal.2.Uncoupling of the blade¿s mechanism: there were discrepancies in the changeover of the wedge of the pulley between maintenance technicians.Even though, the position of the wedge is poka yoke, there was evidence of the usage of incorrect keyway.This affected 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 had been significant variation in the indexation process when pulley belt had 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 were not able to detect sudden failures because the current automation design used technology that were 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 process instruction - chevron sleeve empacado automático linea bodolay, was revised and an opportunity was found regarding 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 rotated on itself, which caused film to move inadequately and made the blister to be cut in seal or dressings to be trapped in seal.7.Uncoupling of the blade¿s mechanism: there were discrepancies in the changeover of the wedge of the pulley between maintenance technicians.Even though, the position of the wedge is poka yoke, there was evidence of the usage of incorrect keyway.This affected 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 had been significant variation in the indexation process when pulley belt had 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 were not able to detect sudden failures because the current automation design used technology that were not up to date.Those failures made the indexation process to make undesired movements of the indexed materials which led 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 process instruction - chevron sleeve empacado automático linea bodolay, was revised and an opportunity was found regarding 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 did not enter properly into the market units while performing the secondary packaging process.Those blisters were 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 process instruction - 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 height 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 applied 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 was above the dressing web.Since dressings were automatically feed in the bodolay machine, the units were 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 process instructions.For dirt 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 were organized into the counter pockets.It is a manual process.This issue caused that the blisters did not enter on the mku¿s, creating defects such as torn or crushed or dirty package.Actions were taken on corrective action / preventive actions (capa) plan.The investigation associated with related event was approved and 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: 9618003.

Event Description

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

• 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 91000 ; DR 91000
• Manufacturer (Section G): CONVATEC DOMINICAN REPUBLIC INC; km 18.5 parque industrial; itabo, s.a. haina; san cristobal 91000 ; DR 91000
• Manufacturer Contact: pamela meadows ; 7815 national service road; suite 600; greensboro, NC ; 3365424679
• MDR Report Key: 12877297
• MDR Text Key: 285463863
• Report Number: 9618003-2021-02733
• 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: Foreign,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 11/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 187957
• Device Lot Number: 1C01608
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 11/01/2021
• Initial Date FDA Received: 11/26/2021
• Supplement Dates Manufacturer Received: 11/26/2021
• Supplement Dates FDA Received: 12/17/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1