MAUDE Adverse Event Report: CONVATEC DOMINICAN REPUBLIC INC ACTIVELIFE; BAG, URINARY, ILEOSTOMY

Model Number 125363

Device Problem Malposition of Device (2616)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Mdr 9618003-2019-05260 / device 3 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

It was reported the starter hole was off center which caused a decrease in wear time.No photograph was provided.No harm was reported.

Manufacturer Narrative

Batch record review: lot 9c01362 was manufactured on 03/12/2019, in the convex 1pc line with a total of (b)(4) ea.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, under icc code 125363, sap material id 1172462 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 the process instructions pi21-076.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 ¿ost-pmc1.8 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 pi21-076 rev 37.0 specifications; however, as part of this investigation on 10/may/2019, maintenance and facilities manager ((b)(6)) 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: 2) process / method investigation: a) 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.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 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 instructions 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: BAG, URINARY, ILEOSTOMY
• 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: 8960109
• MDR Text Key: 156441687
• Report Number: 9618003-2019-05260
• Device Sequence Number: 1
• Product Code: EXH
• 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: 09/04/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/27/2024
• Device Model Number: 125363
• Device Lot Number: 9C01362
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 10/23/2023
• 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
• Patient Sex: Female