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)

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

Event Type  malfunction  

Event Description

It was reported that there was foreign matter particle inside the dressing packaging.The product was not used by patient.Photographs depicting the issue were received from the complainant.

Event Description

It was reported that there was foreign matter particle inside the dressing packaging.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.Batch record review: the lot 1e01721 was manufactured on 06 june 2021, bodolay manufacturing line, with a total of (b)(4) market units.Complaint investigator performed a batch record review on 08 sep 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.System application product (sap) material (b)(4) 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: investigation conclusion.The purpose of this investigation was to identify the potential causes for the complaints reported for the malfunction - foreign matter within product, sterile products (e.G.Metal contamination in dressings, particulates within fluids, gels etc) and foreign matter (e.G.Hairs, insects) within primary pack (sterile products), in products manufactured on manufacturing lines listed in attachment#1, as well as the corresponding corrective and preventive actions required to prevent issue re occurrence.As part of the preliminary investigation for the nonconformance, the impact was determined as major since the failure was a quality attribute detected by existing detection methods and product effectiveness could have an adverse impact.The risk level based on the individual risk acceptability criteria and risk evaluation above is moderate, meaning that risks are broadly accepted but further risk control measures shall be considered if they are feasible and will reduce the risk further.The complaints as described have been reviewed and does not represent a threat to public safety.In addition, as per work instructions (wi), the severity reported for those cases is high.For these reasons, a corrective and preventive actions (capa) plan will be generated.After brainstorming and ishikawa, potential root cause to the failure mode was identified.Corrective and preventive actions will be taken for each of the causes identify for problem solution.Root cause(s): method: dirty carts to transport materials.Dirty trays.Solution: create cleaning process of trays and cars used to managed materials in cleaning room during the manufacturing process.Method: mixers with residues from previous mixtures.Solution: include new cleaning process in the clean schedule.Manpower: inadequate transfer of materials.Solution: retrain warehouse and manufacturing personnel in the correct materials transfer from warehouse to the cleaning room per standard operating procedure (sop).Manpower: inadequate electrocuting lamp maintenance.Solution: retrain the personnel involved in the correct verification of the electrocuting lamp per work instructions (wi).A corrective and preventive actions (capa) plan will be generated to track the implementation of these actions and measure the effectiveness in the product and the process.The investigation has been approved and is completed.No additional action is required, and this complaint will be closed.This issue will be monitored through the post market product monitoring review process, standard operating procedure (sop).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: 13583239
• MDR Text Key: 285986575
• Report Number: 9618003-2022-00205
• 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,Company Representative,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 01/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 187957
• Device Lot Number: 1E01721
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2022
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 09/09/2022
• Date Device Manufactured: 06/06/2021
• 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