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

Model Number	175784
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device 2 of 5.(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 or Problem Description
It was reported that 5 unused wafers had an off centered starter hole.No photo is available at this time.
Additional 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.Batch record review: lot 9j02223 was manufactured on 10/01/2019, in the convex 1 pc line.A batch record review was performed 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) 175784, system application product (sap) material id 1000631 and manufacturing order (b)(4).The batch record review supports that there were no discrepancies related to the issue reported.The testing results were found satisfactory and 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 pi21-076.The process requirements results were documented in the manufacturing batch record mr21-076.The product was packed and labeled under the packaging and labeling specification 1000631.Photograph, video and/or physical sample evaluation: there are no photographs associated with this case and no unused return sample has been received for this complaint.Conclusion summary of the related event: 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.Opportunity of improvement in the detection method: there is not a visual aid for the off-center defect recognition for active life pouches, in the manufacturing line of convex 1pc.A corrective / preventive actions (capa) was opened to address the 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 or Problem Description
To date no additional patient or event details have been received.

• Brand Name: ACTIVELIFE
• Common Device Name: 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: 10506128
• Report Number: 9618003-2020-13547
• Device Sequence Number: 16892153
• Product Code: EZQ
• UDI-Device Identifier: 00768455181308
• UDI-Public: 00768455181308
• Combination Product (Y/N): N
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 09/29/2024
• Device Model Number: 175784
• Device Lot Number: 9J02223
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/18/2020
• Supplement Date Received by Manufacturer: 11/20/2023
• Initial Report FDA Received Date: 09/09/2020
• Supplement Report FDA Received Date: 11/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/01/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown