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

Model Number 187955

Device Problems Delivered as Unsterile Product (1421); Contamination /Decontamination Problem (2895)

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

Event Type  malfunction  

Manufacturer Narrative

Device 1 of 5.Complainant street address: (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 (b)(4).

Event Description

It was reported that the foreign matter inside packaging was found during inspection.The product was not used by patient.Photographs depicting the issues were received from the complainant.

Manufacturer Narrative

Batch record review: the lot 1f02867 was manufactured on 06/22/2021, bodolay manufacturing line, with a total of (b)(4) market units.Complaint investigator id (b)(4) performed a batch record review on 08/30/2022, 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 1704768 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 is to identify the potential causes for the complaints reported for the malfunction code ¿wnd-pmc08.02 foreign matter within product, sterile products (e.G.Metal contamination in dressings, particulates within fluids, gels etc) ¿ and ¿wnd-pmc09.09 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 is 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 (b)(4) complaints process (trackwise (b)(4)): manufacturing site investigations¿, version 5.0, the severity reported for those cases is high.For these reasons, a 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 dr-sop-0007.Manpower: inadequate electrocuting lamp maintenance solution: retrain the personnel involved in the correct verification of the electrocuting lamp per (b)(4).A capa plan will be generated to track the implementation of these actions and measure the effectiveness in the product and the process.No additional details have been provided to date.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: 14191746
• MDR Text Key: 289961030
• Report Number: 9618003-2022-00468
• Device Sequence Number: 1
• Product Code: NAD
• Combination Product (y/n): N
• PMA/PMN Number: 08/31/2022
• 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: 04/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 187955
• Device Lot Number: 1F02867
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 08/31/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/22/2021
• 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