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

Model Number 187957

Device Problems Delivered as Unsterile Product (1421); Unsealed Device Packaging (1444); Packaging Problem (3007)

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

Event Date 02/01/2022

Event Type  malfunction  

Manufacturer Narrative

Device 2 of 5.Complainant street address: (b)(6).Complainant city: (b)(6).Complainant state/province: (b)(6).Complainant postal code: (b)(6).Complainant phone: (b)(6).Patient country: (b)(6).Name of affiliation: (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.Fda registration number reporting site: (b)(4).

Event Description

It was reported that seal was incomplete and dressing was compressed.The product was not used by patient.Photographs depicting the issue were received from the complainant.

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 batch record review: the lot 1e03392 was manufactured on 03 june 2021 bodolay manufacturing line, with a total of (b)(4) market units.Complaint investigator performed a batch record review on 28 october 2022, to verify if all the applicable procedures were followed and no issues were found; all the components for assembly were correct per bill of materials (bom) and all the tooling information documented was also correct.Sap (system application product) material 1704769 and manufacturing order (b)(4).The batch record review supports that there were no discrepancies related to the issue reported.Returned sample evaluation: photo related to the reported problem is available for evaluation.Conclusion summary of the related event: root cause investigation the purpose of this root cause investigation was identified probable causes and takes the appropriate corrective and preventive actions in order to solve the failure mode "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¿ on bodolay machine.The failure modes for open seal covered were: 1.Cut in seal or edge of packaging is cut 2.Trapped in seal or caught in seal 3.Torn or crushed 4.Region not sealed 5.Channel in the seal 6.Weak welding based in the analysis phase conclusions, the issue of 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, it can be concluded that most of the causes are related to machine conditions and also to rework method which is mainly performed by manpower originated at the primary packaging operation.Summary of causes identified for open seal: 1.Variation in the indexation process.2.Misalignment of the sealing station 3.Unclear steps for rework process.Most of these failures had been covered in previous investigations.Lots affected with complaints reported were manufactured before those actions were implemented.Corrective and preventive actions will be taken for each of the causes identify for problem solution.Refer to capa (corrective and preventive actions) plan for the list of actions.Capa (corrective and preventive actions) plan root cause(s) / issue to be addressed: based in the analysis phase conclusions, the issue of 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 this malfunction, the root causes found were: machine: a 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.B.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: 5.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.6.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.7.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.8.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: c.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 procedure instruction (pi) - 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.Root cause investigation on date october 18, 2021, during the inspection process in bodolay line, was found two (02) units with open seal by the manufacturing personnel.The affected product belongs to order 1594500 lot no.1k01072 and item 1704761.As per work instruction (package seal integrity nonconformities), open seals are not allowed this root cause investigation was generated to identify probable causes and takes the appropriate corrective and preventive actions in order to solve the defect of open seal on bodolay pratt c.The purpose of the root cause investigation was identifying the probable causes and takes the appropriate corrective and preventive action to avoid the generation of the defect of ¿open seal¿ on bodolay c line.In order to determine the possible causes of the defect of open seal an analysis of the six m¿s was performed; the following potential causes were identified related to method: 1.Quantity of dressing to place in the loading not defined: based in the difference of the thickness and the materials for the extra thin and control gel formula (cgf) dressing can affect the quantity of dressing that are taken and placed into the conveyor causing the defect of trapped dressing that in the case of control gel formula (cgf) product, because of its thickness, the sealing of the subsequent / previous unit not sealed will be affected by poorly seal (open seal).Action: standardize the correct quantity of dressings to be placed in the loading and update the applicable document.2.Detection method not stablished: however, the defect caused when a control gel formula (cgf) product is affected by a trapped dressing because of its thickness and the sealing of the subsequent / previous unit not sealed will be affected by poorly seal (open seal) is not covered under the previous validated vision systems.Action: improve the vision system to include the detection of open units in the seal area 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: 14730141
• MDR Text Key: 298108721
• Report Number: 9618003-2022-00613
• Device Sequence Number: 1
• Product Code: NAD
• UDI-Device Identifier: 00768455150939
• UDI-Public: 00768455150939
• 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: 05/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 187957
• Device Lot Number: 1E03392
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 10/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/03/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1