MAUDE Adverse Event Report: CONVATEC DOMINICAN REPUBLIC INC L3O0100 - ACTIVE LIFE; POUCH, COLOSTOMY

Model Number 175783

Device Problem Malposition of Device (2616)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Device 2 of 10.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 10 out of 2 boxes of 5 appliances had an off centered starter hole.The products were not used.A picture of the alleged malfunction was provided by the end user.

Event Description

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

Manufacturer Narrative

(b)(6).Batch record review: lot 0g00085 was manufactured on 08/10/2020, in the convex 1pc line with a total of (b)(4) ea.Compliance engineer id 6054 performed a batch record review on 02/26/2021, 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 175783, sap material id 1000628 and manufacturing order 1510462.The batch record review supports that there were no discrepancies related to the issue reported.Photograph, video and/or physical sample evaluation: there are photographs associated with this case and in these, the reported defect can be seen.No unused return sample was expected.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 capa plan was generated for the mitigate the root causes identified.To date no additional information has been received.Should additional information become available, a follow-up report will be submitted.Fda registration number: reporting site: 1049092.Manufacturing site: 9618003.

• Brand Name: L3O0100 - ACTIVE LIFE
• Type of Device: POUCH, COLOSTOMY
• Manufacturer (Section D): CONVATEC DOMINICAN REPUBLIC INC; km 18.5 parque industrial; itabo, s.a. haina; san cristobal
• MDR Report Key: 11347632
• MDR Text Key: 232586904
• Report Number: 9618003-2021-00258
• 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
• Type of Report: Initial,Followup
• Report Date: 02/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 175783
• Device Lot Number: 0G00085
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 02/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1