MAUDE Adverse Event Report: CONVATEC DOMINICAN REPUBLIC INC L3O0215 - NATURA+; POUCH, COLOSTOMY

Model Number 416418

Device Problems Fluid/Blood Leak (1250); Malposition of Device (2616)

Patient Problem Distress (2329)

Event Type  malfunction  

Manufacturer Narrative

Device 2 of 5.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

The end user reported that five wafers with moldable starter hole was off centered which contributed to undermining of wafer with stool within less than one to two days wear time, therefore, required removal and replacement of device.The end user reported typical wear time of six to seven days.She also explained the skin care preparation prior to wafer application by cleansing with warm water, pat dried and then, eakin cohesive seal was applied after molding to fit to the back of the wafer aligning with stoma opening in order apply the wafer and secure the pouch.Consumer declined the use of additional accessories such as wipes or pastes due to skin sensitivities to alcohol content.Consumer reported that pouch was worn with a slight angle towards left side, denied the use of ostomy standard belt, hernia belt or wrap; emptied the pouch when one-third to half was full and reported typical liquid output.No photo is available at this time.There was no physical harm experienced by customer, but embarrassment was reported from wafer leakage and an associated odor.

Event Description

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

Manufacturer Narrative

Batch record review: lot 1e00669 was manufactured on 05/17/2021, convex 2 pc manufacturing line, with a total of (b)(4).Complaint investigator id (b)(4) performed a batch record review on 30/06/2022 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 1156501 and manufacturing order (b)(4).The batch record review supports that there were no discrepancies related to the issue reported.Complaint data analysis: on 30/06/2022, complaint investigator id 6055 performed a search of complaints into trackwise system for lot number 1e00669.As a result, a total of 03 complaints were found reported and 01 is related to the same malfunction code of this investigation.Returned sample evaluation: no photograph associated with this case was received and no unused return sample was expected.Conclusion summary of the related event: the purpose of this investigation was to determine the root cause associated investigation wafer disc decentralized, complaint malfunction codes ost-pmc1.8 / 1.18 (skin barrier starter hole is defective, misalignment or off center, leakage may occur), for lots manufactured in convex 2 pc awc facilities, haina d.R.The highest severity rating reported was 4 which is considered serious.Also, the risk level based on the individual risk acceptability criteria and risk evaluation above is medium, meaning that these risks may be accepted but further risk control measures shall be considered if they are feasible and will reduce the risk further.Risks judged moderate are considered acceptable based on an acceptable risk-benefit profile and must be assessed for the need for post market surveillance.After understanding the process, a brainstorming tool was used to determine all the possible causes of the problem; the cause & effect diagram was used and as a result there were found seven (7) potential causes identified.One (1) of them were discarded, and six (6) were confirmed and retained as root/probable cause for the failure.Based on the investigation findings, the root causes for wafer decentralized were identified as manpower, method and machine, see the table below for details: probable root cause: manpower: 1.Procedure pi21-139 (convex 2pc wafer sub assembly machine 2, section 7.1.13 ¿ 7.1.14) not followed by manufacturing personnel while placing the mass on loading pins.2.Manufacturing inspections failed to be executed as per tm-017 and mr21-139.Machine: 3.Pistons defective.4.Base thread of k tool loading pin defective.5.Electro-valve damaged.Method: 6.Manufacturing inspections failed to be executed as per tm-017 and mr21-139.The capa plan tw# 1461582 was generated to cover the probable causes, taking appropriate actions and measure its effectiveness.No additional details have been provided to date.Should additional information become available, a follow up report will be submitted.Reporting site: 1049092.Manufacturing site: 9618003.

• Brand Name: L3O0215 - NATURA+
• Type of Device: POUCH, COLOSTOMY
• 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: 14513823
• MDR Text Key: 292717592
• Report Number: 9618003-2022-00563
• Device Sequence Number: 1
• Product Code: EZQ
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 416418
• Device Lot Number: 1E00669
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 06/30/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/17/2021
• 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
• Patient Sex: Female