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

Model Number 403326

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  

Manufacturer Narrative

Device 1 of 10.Complainant country : poland.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 there was round stain or dirt on the dressing inside the packaging.The product was not used.The photographs were received from the complainant depicting the issue.

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: lot 1j03597 was manufactured on 04 october 2021, in the uhlmann #2 line with a total of (b)(4) market units.Complaint investigator performed a batch record review on 26 december 2022, to verify if all the applicable procedures were followed system application product (sap) material id 1227033 and manufacturing order (b)(4).Photo related to the reported problem is available for evaluation.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 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 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: 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: 16050204
• MDR Text Key: 308454022
• Report Number: 9618003-2022-05412
• 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: 12/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 403326
• Device Lot Number: 1J03597
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 12/26/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/04/2021
• 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