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

Model Number 187955

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Device 3 of 14.(b)(6).Based on the available information, this event is deemed to be a reportable malfunction.Lot#: 9h00191 was manufactured on 08/13/2019 in the bodolay line with a total of (b)(4)market units.Complaint investigator id#: (b)(4) performed a batch record review on 11/18/2020 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# (b)(4) sap material id: 1704768 and manufacturing order#: (b)(4).The batch record review supports that there were no discrepancies related to the issue reported.Photo related to the reported problem is available for evaluation.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 (b)(6).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 cause: the frequency of the mixer cleaning was not adequate when the mixer was run at the upper end of the validated settings.Contributing cause: 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.To date, no additional patient/event information has been received.Should additional information become available, a follow-up report will be submitted.(b)(4).

Event Description

The end user claimed that there were black spots in dressing.The product was used by end user.There was no harm reported.A photograph depicting the issue was received from the end user.

• Brand Name: L3W0750
• Type of Device: DRESSING,WOUND,OCCLUSIVE
• Manufacturer (Section D): CONVATEC DOMINICAN REPUBLIC INC; km 18.5 parque industrial; itabo, s.a. haina; san cristobal
• Manufacturer (Section G): CONVATEC DOMINICAN REPUBLIC INC; km 18.5 parque industrial; itabo, s.a. haina; san cristobal
• Manufacturer Contact: jeanette johnson ; 7900 triad center drive; suite 400; greensboro, NC 27409 ; 3365424681
• MDR Report Key: 10903778
• MDR Text Key: 219188694
• Report Number: 9618003-2020-15391
• 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: consumer,distributor,foreign
• Type of Report: Initial
• Report Date: 11/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 187955
• Device Lot Number: 9H00191
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/03/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/13/2019
• 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