MAUDE Adverse Event Report: CONVATEC DOMINICAN REPUBLIC INC ESTEEM +; POUCH, COLOSTOMY

Model Number 416740

Device Problems Malposition of Device (2616); Positioning Problem (3009)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Device 8 of 12.(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

The end user reported that the product was off centered.Due to off center, the products kept detaching from skin.There was no harm reported by the end user.No photo is available at this time.

Manufacturer Narrative

Additional information - this emdr is being submitted to include the below: d4: unique identifier (udi).H6: investigation results under imdrf cause investigation code, imdrf investigation findings, imdrf cause conclusions.H10: investigation summary.An investigation was completed for this complaint by the assigned manufacturing site investigation team.The complaint summary of this investigation required rework.A corrective actions/preventive actions (capa) was raised, and an updated/corrected investigation summary has been completed in accordance with assigned capa.A supplemental mdr is being submitted to document the completion of investigation rework and final investigation; the complaint record will proceed to closure.Batch record review: lot 9f01941 was manufactured on 06/26/2019, in the convex 1pc line with a total of (b)(4) ea.Compliance engineer performed a batch record review on 08/08/2020, to verify if all the applicable procedures were followed and no issues were found, all the components for assembly were correct per bill of materials (bom) and all the tooling information documented was also correct, under international commodity code (icc) code 416740, system application product (sap) material id 1703550 and manufacturing order (b)(4).The batch record review supports that there were no discrepancies related to the issue reported.The crew requirements and responsibilities, process parameters, quality and in-process inspections, line operations, process troubleshooting and relevant documents to the process were run according to the process instructions (pi).Photograph, video and/or physical sample evaluation: no photograph associated with this case were received.No unused return sample has been received for this complaint.Conclusion summary of the related event: based in the investigation findings, the root cause identified for the issue ¿wafer off center in the pouch¿, reported under failure mode ¿skin barrier starter hole is defective (e.G misalignment or off center), leakage may occur¿ is attributed to: 1) machine: the investigative process concluded that all the machinery/ tooling items used in the manufacturing process complied when compared against drawing and process instruction (pi) specifications; however, as part of this investigation on 10/may/2019, maintenance and facilities manager and senior process engineer performed a deep assessment to the sub-assembly station of the convex 1-piece (pc) machine identifying the conditions causing the wafer off center and the possible solutions to correct the failure.As conclusion of the assessment, the chain that coordinates flange loading station with adhesive loading station needed lubrication and the chain and other components of the mechanism needed a corrective maintenance.In order to maintain this condition in the long term, a deeper intervention of the mechanism is required.Furthermore, regarding the rotary table station of the convex 1-piece (pc) machine, it was identified that due to the demands of the process, the tooling used to manufacture the urodress product family require a redesign modification to reduce the variability within the manufacturing process.As a contributor factors the following opportunities for improvements were identified: 2) process / method investigation: a) reference in the process instruction (pi), the applicable quality control (qc) tooling used for product¿s quality inspection purpose of pouch uro 177a products family in order to address manufacturing personnel the use of them.B) identification of the defect during the manufacturing process, it should be considered the implementation of a job aid for product centralization out of specification.3) process / method / measurement investigation: a) introduce quality control (qc) tooling used for product¿s quality inspection purpose in the calibration program to guarantee measurement assurance.4) manpower: a) there are not manpower causes associated with the root cause; even though, opportunity to improve the loading of the adhesive disc during the manufacturing process was identified by implementing a standard work instruction for convex 1-piece (pc) to indicate manufacturing operators how to properly load the adhesive disc.No issues were identified for material and environment investigations.A corrective actions/preventive actions (capa) plan was generated for the mitigate the root causes identified.The investigation associated with related event has been approved and is 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.Reporting site: 1049092.Manufacturing site: 9618003.

Event Description

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

• Brand Name: ESTEEM +
• Type of Device: POUCH, COLOSTOMY
• 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: pamela meadows ; 7815 national service road; suite 600; greensboro, NC 27409 ; 3365424679
• MDR Report Key: 10229459
• MDR Text Key: 198072025
• Report Number: 9618003-2020-12359
• Device Sequence Number: 1
• Product Code: EZQ
• UDI-Device Identifier: 00768455188499
• UDI-Public: 00768455188499
• 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,Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 416740
• Device Lot Number: 9F01941
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 11/15/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1