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

Model Number	650830
Medical Device Problem Codes	Malposition of Device (2616); Positioning Problem (3009)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device 4 of 9.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
The end user reported reduced wear time in 4 appliances from box of 10.He stated that 5 of 6 remaining in the box were also off centered and he declined to use them.His wear time was usually 3 to 4 days, which was reduced to less than 48 hours.He attributed this to the off centered hole.The end user stated that "i have used these over the last 10 years and i have noticed the quality has gone down in the workmanship of the products".There was no harm reported and no photo is available at this time.
Additional Manufacturer Narrative
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 0b03803 was manufactured on 02/26/2020, in the convex 1pc line with a total of (b)(4) ea.Compliance engineer 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 bill of materials (bom) and all the tooling information documented was also correct, under international commodity code (icc) code 650830, system application product (sap) material identification (id) 1004088 and manufacturing order (b)(4).The batch record review supports that there were no discrepancies related to the issue reported.Photograph, video and/or physical sample evaluation: no photographs associated with this case were received and no unused return sample was expected.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 ¿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 process instruction (pi) pi21-076 rev 37.0 specifications; however, as part of this investigation on 10/may/2019, maintenance and facilities manager and senior process engineer 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 manufacture 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 process instruction (pi) 21-076; 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 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 corrective actions/preventive actions (capa) plan was generated for the 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.Fda registration number 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: 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: 10669759
• Report Number: 9618003-2020-14878
• Device Sequence Number: 16864189
• Product Code: EXH
• UDI-Device Identifier: 00768455190249
• UDI-Public: 00768455190249
• Combination Product (Y/N): N
• Initial Reporter State: NC
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/17/2020

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: 02/25/2025
• Device Model Number: 650830
• Device Lot Number: 0B03803
• 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: 09/17/2020
• Supplement Date Received by Manufacturer: 11/03/2023
• Initial Report FDA Received Date: 10/13/2020
• Supplement Report FDA Received Date: 11/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/26/2020
• 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: Male