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

Model Number 175777

Device Problem Malposition of Device (2616)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

(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

It was reported that 13 "pre-cut starter hole of the wafer (skin barrier) was not aligned well at the centre position of the pouch".Photos depicting the reported complaint issue were provided by the complainant.Not used, no harm reported.

Manufacturer Narrative

Batch record review: lot 7l02692 was manufactured on 11/18/2017, in convex 1 pc line, with a total of (b)(4) market units.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 bom and all the tooling information documented was also correct, sap material id 1000616 and manufacturing order (b)(4).The bulk for this product was manufactured in the line guard under lot number 7k02930 description pch estinvisi drn std wf tan lg cvx eur, sap material 1002581, quantity 68,000.Manufacturing date 10/17/2017, order number 1371359.The batch record review supports that there were no discrepancies related to the issue reported.Photograph, video and/or physical sample evaluation: there are six photograph(s) associated with this case and in these, the defect reported by the customer can be seen.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 ¿ost-pmc1.8 skin barrier starter hole is defective (e.G misalignment or off center), leakage may occur¿ is attributed to: machine: the investigative process concluded that all the machinery/ tooling items used in the manufacturing process complied when compared against drawing and pi21-076 rev 37.0 specifications; however, as part of this investigation on 10/may/2019, maintenance and facilities manager (aurys arias) and senior process engineer (b)(6) performed a deep assessment to the sub-assembly station of the convex 1pc 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 1pc machine, it was identified that due to the demands of the process, the tooling (cup pouch uro 177a) used to manufactured 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: process / method investigation: reference in the pi21-076; section 8.0 ¿quality instructions¿ the applicable 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.Identification of the defect during the manufacturing process, it should be considered the implementation of a job aid for product centralization out of specification.Process / method / measurement investigation.Introduce qc tooling used for product¿s quality inspection purpose in the calibration program to guarantee measurement assurance.Manpower: 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 1pc to indicate manufacturing operators how to properly load the adhesive disc.No issues were identified for material and environment investigations.A capa plan was generated for the mitigate the root causes identified.Should additional information become available, a follow-up report will be submitted.Fda registration number: reporting site: 1049092.Manufacturing site: 9618003.

Event Description

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

• 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: 8790366
• MDR Text Key: 151025533
• Report Number: 9618003-2019-04701
• 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: Foreign,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup

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
• Device Operator: Other
• Device Expiration Date: 11/17/2022
• Device Model Number: 175777
• Device Lot Number: 7L02692
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 07/04/2019
• Initial Date FDA Received: 07/15/2019
• Supplement Dates Manufacturer Received: 10/16/2023
• Supplement Dates FDA Received: 10/16/2023
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1