MAUDE Adverse Event Report: CONVATEC DOMINICAN REPUBLIC INC AQUACEL AG SURGICAL; DRESSING, WOUND, DRUG

Model Number	412011
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
Additional Manufacturer Narrative
E1: complainant street address: (b)(6).Based on the available information, this event is deemed to be a reportable malfunction.Batch record review: lot 2l02199 was manufactured on 11/24/2022, in surgical cover dressing (scd) packaging line, with a total of (b)(4) market units (mkus).The complaints investigator performed a batch record review on 27/mar/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 identification (id) 1257756 and manufacturing order (b)(4).Review of the batch record showed that all relevant tests required during the manufacturing process and final product release had been fulfilled and met the requirements.No discrepancy related to this issue were found within the documentation.Photograph, video and/or physical sample evaluation: there is a photograph associated with this case and in this, the reported defect can be seen.No unused return sample was expected.Conclusion summary of the related event: based on the revision of the observation of the processes involved, interviews to the personnel of the line and the expertise of the triage team, this failure mode was attributed to the following probable causes: method: dirty carts to transport materials.Dirty trays.Mixers with residues from previous mixtures.Manpower: inadequate transfer of materials.Inadequate electrocuting lamp maintenance.Corrective and preventive actions identified will be taken through corrective action / preventive actions (capa) plan.The investigation associated with related event record has been approved and was 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.
Event or Problem Description
The distributor reported that complaint received from hospital about product discoloration, part of dressing color was darkened.The product was not used on patient.Photographs depicting the issue were received from the complainant.

• Brand Name: AQUACEL AG SURGICAL
• Common Device Name: DRESSING, WOUND, DRUG
• 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 27409 ; 3365424679
• MDR Report Key: 19094778
• Report Number: 9618003-2024-00527
• Device Sequence Number: 20689952
• Product Code: FRO
• UDI-Device Identifier: 00768455124299
• UDI-Public: 00768455124299
• Combination Product (Y/N): N
• PMA/510(K) Number: K091034
• 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): 03/18/2024

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 Expiration Date: 11/01/2025
• Device Model Number: 412011
• Device Lot Number: 2L02199
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/18/2024
• Initial Report FDA Received Date: 04/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/24/2022
• 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