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); Device Contaminated During Manufacture or Shipping (2969)

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

Event Type  malfunction  

Manufacturer Narrative

Device 2 of 4.(b)(6).Based on the available information, this event is deemed to be a reportable malfunction.Batch record review: the lot 1l00735 was manufactured on 11/05/2021, bodolay manufacturing line, with a total of (b)(4) market units.Complaint investigator performed a batch record review on 08/21/2022, 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 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 was available for evaluation.Investigation conclusion: the purpose of this investigation is to identify the potential causes for the complaints reported for the malfunctions - 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, 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 instruction (wi), the severity reported for those cases is high.For these reasons, a corrective/preventative action (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 sop (standard operating procedure).Manpower: inadequate electrocuting lamp maintenance solution: retrain the personnel involved in the correct verification of the electrocuting lamp per work instructions (wi).A corrective/preventative action (capa) plan will be generated to track the implementation of these actions and measure the effectiveness in the product and the process.The investigation associated with related event record 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.(b)(4).

Event Description

It was reported that there was foreign matter inside packaging.It was unknown whether the product used by the patient or not.The photographs depicting the issue were received from the complainant.

• 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: 15291518
• MDR Text Key: 305499596
• Report Number: 9618003-2022-04882
• 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
• Report Date: 07/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 187955
• Device Lot Number: 1L00735
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/28/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/05/2021
• 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