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

Model Number 175778

Device Problem Malposition of Device (2616)

Patient Problem Distress (2329)

Event Type  malfunction  

Manufacturer Narrative

Device 15 of 15.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 noted off centered starter holes on 15 pouches from 6 boxes.Not only was the flange, bandage and pouch off-centered, but the bandage was also cut off centered.So, there was more bandage area on one side and less on the other.Reportedly, 1 from box #1, 2 from box #2, 5 from box #3, 1 from box #4, 5 from box #5 and 1 from box #6 were affected.The end user felt disheartened and reluctant to use the products.Photographs depicting the issue were received from the end user.

Event Description

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

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 0a00439 was manufactured on 09/jan/2020, in convex 1 pc line, with a total of (b)(4)market units.Compliance engineer performed a batch record review on 16/apr/2021, 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, system application product (sap) material id 1000618 and manufacturing order (b)(4).The process carried out was according to process instruction (pi) pi21-0176.Photograph, video and/or physical sample evaluation: based on the photographs provided by the customer, the reported defect can be observed.No unused return sample was received.Conclusion summary of the related event: on 04/jul/2019 complaint was reported related to malfunction skin barrier starter hole is defective (e.G., misalignment or off center), leakage may occur (pre-cut only), with severity rating four (4), for the affected product system application product (sap) 1000616 ¿ active life pch sm clr 19mm, lot number 7l02692, manufacturing line convex 1pc at awc facility.The end user reported that the pre-cut starter hole of the wafer (skin barrier) was not aligned well at the center position of the pouch.Refer to complaint¿s picture received.Since no probable root causes were identified during the preliminary investigation of the nonconformance report, a root cause investigation was generated.Based on the investigation findings, process observation, tooling analysis and personnel interviews, the investigation concluded that the off center on active life products of convex 1pc is originated due to the following root causes: method: - method for wafer placement onto the cups of the lower level of the rotary table is too general.Due to that a wafer placement variation could be found between the different operators, which can potentially cause a wrong placement of wafers, resulting in a nonconforming product impacted by the off-center defect.- method for pouch placement onto slides plates of the upper level of the rotary table is too general.Due to that a pouch placement variation could be found between the different operators, which can potentially cause a wrong placement of wafers resulting in a nonconforming product impacted by the off-center defect.- not standardized method for the installation of slide plates into the rotary table of convex 1pc.- not standardized method for the installation of cups into the rotary table of convex 1pc.Machine: -worn out guides for slide plates, do not allow guides to properly adjust during the manufacturing process, causing misalignment between pouches and wafers.- incorrect adjustment of cups due to the use of the worn-out screws.- rotation of the glue welding heads causes wafers and pouches decentralization during the assembly process.The corrective actions/preventive actions (capa) plan was generated to 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.

• Brand Name: ACTIVELIFE
• 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: 10041811
• MDR Text Key: 190481731
• Report Number: 9618003-2020-10875
• Device Sequence Number: 1
• Product Code: EZQ
• UDI-Device Identifier: 00768455181247
• UDI-Public: 00768455181247
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 175778
• Device Lot Number: 0A00439
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 10/31/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1