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

Model Number	187900
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
The nurse reported that foreign particles were found on the dressings.The product was not used by the patient.A photograph depicting the issue was received from the complainant.
Additional Manufacturer Narrative
Device 2 of 3.E1: complainant city: (b)(6).Complainant state: (b)(6).Complainant country: peru.Name of affiliation: cardio perfusion e.I.R.L patient city: (b)(6).Patient state: (b)(6).Patient country: peru.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: 1049092, manufacturing site: 9618003.
Event or Problem Description
To date no additional patient or event details have been received.
Additional Manufacturer Narrative
Additional information - this emdr is being submitted to include the below: h6: investigation results under type of investigation, investigation findings, investigation conclusions 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.Batch record revision results: lot 3d04593 was manufactured on 08/ may 2023, in doyen b manufacturing line, with a total of (b)(4) market units (mkus).The complaints investigator performed a batch record review on 05/10/2024, 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) 1704764 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.Historical complaints review: on 05/10/2024, complaints investigator ran a query in database in order to verify the complaints reported for the 3d04593 lot for the malfunction code ¿foreign matter within product, sterile products (e.G.Metal contamination in dressings, particulates within fluids, gels etc)¿ defect and no additional complaints were identified.Historical nonconformance review: on 05/10/2024, complaints investigator ran a query in database looking for any in process nonconformance / corrective action / preventive actions (capa) (s) associated to the malfunction code ¿foreign matter within product, sterile products (e.G.Metal contamination in dressings, particulates within fluids, gels etc)¿ defect for the lot number 3d04593 and as result, no nonconformance / corrective action / preventive actions (capa) (s) for this malfunction code were generated during the manufacturing process of the referenced lot.Defect rate analysis: there have only been 3 defective parts confirmed to date from a lot size 198,000 products.This represents a defect rate of only 0.0015% which is well within an appropriate acceptable quality level (aql) for this defect which should be 1.0 based on our test methods (tm).In addition, all the in-process testing on this lot did not find a single defective unit, which confirms that the lot is unlikely to breach an acceptable quality level (aql) of 1.0 this issue certainly appears to be an isolated incident, but more importantly to date, it is well within our accepted acceptable quality level (aql) level for this type of failure mode or defect.Conclusions: as photographs was available for this complaint issue, it was evaluated and as a result, the reported malfunction for the observed product was confirmed, however, after performing the defect rate analysis for this issue, it was observed that the quantity of reportedly affected products is within the appropriate acceptable quality level (aql) for this defect.A batch record review was completed and 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.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 27409 ; 3365424679
• MDR Report Key: 19286177
• Report Number: 9618003-2024-01902
• Device Sequence Number: 12868358
• Product Code: NAD
• UDI-Device Identifier: 00768455175048
• UDI-Public: 00768455175048
• 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,Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/17/2024

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: Health Professional
• Device Model Number: 187900
• Device Lot Number: 3D04593
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/17/2024
• Supplement Date Received by Manufacturer: 05/13/2024
• Initial Report FDA Received Date: 05/10/2024
• Supplement Report FDA Received Date: 06/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/08/2023
• 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