MAUDE Adverse Event Report: CONVATEC DOMINICAN REPUBLIC INC DUODERM/GRANUFLEX/DUOACTIVE - MOISTURE RETENTIVE DUODERM CGF DRESSING; 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

Mdr 9618003-2019-05158 / device 7 of 9.(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 ¿black spot found on the dressing.¿ a photograph depicting the reported complaint issue was provided by the complainant.

Manufacturer Narrative

A targeted root cause investigation for this known issue/malfunction code has been conducted.The manufacturing process, quality inspections, and quality control records were reviewed.As part of the root cause investigation, dressings with the alleged foreign matter spots were sent to an external lab to have the spots isolated from the dressing for composition testing and analysis.The result of the analysis concluded that the spots were a raw material ingredient used in the formulation of the hydrocolloid.Effects of mixing the hydrocolloid at allowable temperature variations was performed at our manufacturing facility in haina, dominican republic.The results showed that within our validated processing specifications, the number and size of spots present in the hydrocolloid could vary based on the validated range of temperature and time profiles of the mixing process.The investigation found one root cause and two contributing causes for the reported malfunction and they are as follows: root cause: the validated allowable range for the temperature and time profiles of the mixing process allowed for a raw material to become charred during the process at the higher settings.Contributing causes: the frequency of the mixer cleaning was not adequate when the mixer was run at the upper end of the validated settings.The material specification for a powdered raw material used in the formulation allow for black spots.The black spots within the powder cannot be isolated and removed.The material is supplied with a certificate of analysis guaranteeing the product conforms to specification and is safe for use.As a result of the investigation, the mixing temperature and time profiles were tested under engineering studies to find the optimum set point and allowable range to prevent the charring of any of the raw materials.This optimum setting has been fully validated and the change is awaiting regulatory body approval to begin production.In addition, the cleaning frequency of the mixer has been increased to every two batch runs to ensure no potential charred material may begin to build up and eventually become present in our dressings.Product monitoring reviews will monitor for product trends if this issue were to reoccur.No additional patient/event details have been provided to date.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: DUODERM/GRANUFLEX/DUOACTIVE - MOISTURE RETENTIVE DUODERM CGF DRESSING
• 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: 8898308
• MDR Text Key: 154585990
• Report Number: 9618003-2019-05158
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: 187957
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 09/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1