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

Model Number 187957

Device Problems Delivered as Unsterile Product (1421); Device Contamination with Chemical or Other Material (2944)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Device 1 of 2.Initial reporter: (b)(6).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).

Event Description

It was reported that there was foreign body (paper) found on the dressing.The product was not used on patient.A photograph depicting the issue was received from the complainant.

Event Description

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

Manufacturer Narrative

Correction (g1) - contact office address: dr.(b)(6).Batch record review: lot: 9m01493 was manufactured on 12/11/2019 in the bodolay line with a total of (b)(4) market units.Complaint investigator id: (b)(4) performed a batch record review on 04/30/2021 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, under icc code 187957 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.Should additional information become available, a follow up report will be submitted.Fda registration number: reporting site: 1049092.Manufacturing site: 9618003.

• 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
• MDR Report Key: 11250321
• MDR Text Key: 229324783
• Report Number: 9618003-2021-00164
• 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: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 01/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 187957
• Device Lot Number: 9M01493
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 04/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1