MAUDE Adverse Event Report: CONVATEC DOMINICAN REPUBLIC INC 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 Date 12/01/2023

Event Type  malfunction  

Manufacturer Narrative

E1: (b)(6).Batch record review: lot 2h01898 was manufactured on 17 aug 2022, in bodolay line, with a total of (b)(4) market units.The complaint investigator performed a batch record review on 08/dec/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 id 1704768 and manufacturing order (b)(4).The batch record review supports that there were no discrepancies related to the issue reported.Photograph, video and/or physical sample evaluation: photographs associated with this case were received and in these, the reported defect can be observed, unused return samples are available for evaluation.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 action (capa) plan.The investigation associated with related event 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.

Event Description

The distributor reported that there was a red particle foreign body.The product was not used on patient.Photographs depicting the issue were received from the complainant.

• 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: 18418648
• MDR Text Key: 331600300
• Report Number: 9618003-2023-15331
• Device Sequence Number: 1
• Product Code: NAD
• UDI-Device Identifier: 00768455150922
• UDI-Public: 00768455150922
• 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: 12/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 187955
• Device Lot Number: 2H01898
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 01/12/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/17/2022
• 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