MAUDE Adverse Event Report: CONVATEC DOMINICAN REPUBLIC INC L3W0750 - DUODERM; DRESSING,WOUND,OCCLUSIVE

Model Number 187957

Device Problems Unsealed Device Packaging (1444); 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 2.(b)(6).Based on the available information, this event is deemed to be a reportable malfunction.Batch record review: lot 1b03775 was manufactured on 03/06/2021 in the bodolay line with a total of (b)(4).Complaint investigator id (b)(4) performed a batch record review on 11/20/2021 to verify if all the applicable procedures were followed and no issues were found; all the components for assembly were correct per bom and all the tooling information documented was also correct, sap material id (b)(4) 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 is available for evaluation.Investigation summary: based in the analysis phase conclusions.For extra material in seal or foreign matter the root causes found were: manpower: incorrect dressing inspection: residues of paper and film stick to dressing after elc (extrusion lamination and cutting) process, since the scrap collector is above the dressing web.Since dressings are automatically feed in the bodolay machine, the units are packaged without the operator and vision system noticing.An opportunity was found related to the inspection process performed by the elc 10 and elc 11 since dressings must be inspected 100% as per applicable pi31-103 ver 17.0 and pi31-141 ver 7.0.For dirty on package (black stain) the root causes found were: method: unclear steps to perform online rework: an opportunity was found since there is not a standardized method for the segregation and/or rework of the blisters after having a failure or breakdown on the cartoner machine.Wrong placement of blisters (method).During the indexation process of blisters from the primary packaging to secondary packaging, not all blisters are not organized into the counter pockets.It is a manual process.This issue causes that the blisters do not enter on the mku¿s, creating defects such as torn or crushed or dirty package.The investigation associated with related event was approved and complete.No additional action was 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: (b)(4), manufacturing site: (b)(4).

Event Description

It was reported that there was foreign body found on the dressing.The product was not used by customer.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: 12877712
• MDR Text Key: 288849922
• Report Number: 9618003-2021-02748
• 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: 11/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 187957
• Device Lot Number: 1B03775
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/03/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1