MAUDE Adverse Event Report: CONVATEC DOMINICAN REPUBLIC INC L3W0750 - 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 Type  malfunction  

Event Description

It was reported that there was foreign body issue.The product was not used on patient.Photograph depicting the issue was received from the complainant.

Manufacturer Narrative

Initial reporter:(b)(6).Manufacturer location: (b)(4).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.(b)(4).

Manufacturer Narrative

Additional information - this emdr is being submitted to include the below: h6 - investigation results under imdrf cause investigation code, imdrf investigation findings, imdrf cause conclusions.H10: investigation summary.Correction (g1) - contact office address: dr.(b)(6).Batch record review.Lot 1a05354 was manufactured on 01/31/2021 in the bodolay line with a total of (b)(4) market units.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 1704768 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 was 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 were 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 process instructions.For dirt 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 organized into the counter pockets.It is a manual process.This issue caused that the blisters did not enter on the mku¿s, creating defects such as torn or crushed or dirty package.Actions were taken on corrective action / preventive actions (capa) plan.The investigation associated with related event was approved and 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

To date no additional patient or event details have been received.

• 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: 12768986
• MDR Text Key: 284522514
• Report Number: 9618003-2021-02645
• 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,Followup
• Report Date: 10/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 187955
• Device Lot Number: 1A05354
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 11/22/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/31/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1