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

Model Number	187662
Medical Device Problem Codes	Delivered as Unsterile Product (1421); Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/02/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the distributor that there was a black dot on the dressing.The product was not used by patient.Photographs depicting the issue were received from the complainant.
Additional Manufacturer Narrative
E1: complainant street address: (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.Fda registration number.Reporting site: 1049092.Manufacturing site: 9618003.
Additional Manufacturer Narrative
Additional information - this emdr is being submitted to include the below: h6: investigation results under type of investigation, investigation findings, investigation conclusions.H11: investigation summary: batch record review: the lot 3e02944 was manufactured on 20/may/2023, uhlmann#2 manufacturing line, with a total of (b)(4) market units.Complaint investigator performed a batch record review on 04/25/2024, 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.System application product (sap) material 1704763 and manufacturing order (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 photograph associated with this case and in this, the reported defect can be confirmed.No unused return sample was expected.Investigation summary using the 6ms (methods, machines, materials, measurements, mother nature, and manpower) methodology, the followings assignable cause was identified: machine: machine: no proper tools were used to complete the visual inspection at distributor.Distributor was found not familiar with the use of tappi chart for black dot inspection.As the non-conformance is quality system related, with deficiencies in the establishment of the requirements (method) and communication and training related to the inspection and use of the machinery this "m" was discarded.Method: the root cause has been identified in relation to method (inconsistency in the acceptance criteria.No clear inspection/ acceptance criteria was defined for black dot/ foreign matters and dented box defects).Lack of method and training (management responsibility) are the root cause of this issue, specifically in: there is no alignment of inspection method or criteria between distributors and convatec.Man: it was confirmed that the employee(s) at distributor were not trained to convatec inspection criteria.Management: training, communication, resources, management responsibility and prioritization are considered management causes.It was determined that there was no clear instruction nor communication on how distributor should report defects.Distributors send complaints as and when they found it during the labelling process resulting in duplicate complaints for the same defect code within the same manufacturing lot.The investigation associated with related corrective action/preventive action (capa) has been approved and is 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 or Problem Description
To date no additional patient or event details have been received.

• Brand Name: DUODERM
• Common Device Name: 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 27409 ; 3365424679
• MDR Report Key: 19049154
• Report Number: 9618003-2024-00501
• Device Sequence Number: 20671374
• Product Code: NAD
• UDI-Device Identifier: 00768455174928
• UDI-Public: 00768455174928
• Combination Product (Y/N): N
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/13/2024

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
• Operator of Device: Other
• Device Model Number: 187662
• Device Lot Number: 3E02944
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/13/2024
• Supplement Date Received by Manufacturer: 04/26/2024
• Initial Report FDA Received Date: 04/05/2024
• Supplement Report FDA Received Date: 05/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/20/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown