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)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by a distributor that there was a foreign matter inside packaging found during the value added service (vas) activity.The product was not used on patient.A photograph depicting the issue was received from the complainant.
Additional Manufacturer Narrative
E1: (b)(6).Complainant country: philippines.Name of affiliation: getz bros.Philippines, inc.Based on the available information, this event is deemed to be a reportable malfunction.Returned sample evaluation: photo associated with this case was received for evaluation.Batch record review: the lot 2l00496 was manufactured on 09 nov 2022 uhlmann#2 manufacturing line, with a total of (b)(4) units.Complaint investigator performed a batch record review on 17 aug 2023, 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 1662965.The batch record review supports that there were no discrepancies related to the issue reported.Investigation conclusion: 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.Method: mixers with residues from previous mixtures.Manpower: inadequate transfer of materials.Manpower: inadequate electrocuting lamp maintenance.A corrective action / preventive 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.Fda registration number: reporting site: 1049092.Manufacturing site: 9618003.

• 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 ; 3365424679
• MDR Report Key: 17621661
• Report Number: 9618003-2023-02610
• Device Sequence Number: 6154648
• 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
• Report Date (Section B): 07/31/2023

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: 2L00496
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/31/2023
• Initial Report FDA Received Date: 08/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/09/2022
• 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