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U.S. Department of Health and Human Services

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

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CONVATEC DOMINICAN REPUBLIC INC ACTIVELIFE; POUCH, COLOSTOMY Back to Search Results
Model Number 125353
Device Problems Fluid/Blood Leak (1250); Malposition of Device (2616)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
Device 5 of 7.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 stated that the center opening was off centered in wafers.He noticed it when he removed them from the box.Reportedly, the end user used the products and experienced leakage.There was no harm reported by the end user.No photo is available at this time.
 
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 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 8c02898 was manufactured on (b)(6) 2018, in the convex 1-piece (pc) line with a total of 1,300 ea.Compliance engineer performed a batch record review on (b)(6) 2020, 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 (b)(4), system application product (sap) material identification (id) (b)(4) 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 to 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 ¿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 instructions (pi21-076) 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 1-piece (pc) 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 1-piece (pc) machine, it was identified that due to the demands of the process, the tooling 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 instructions (pi21-076); ¿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 quality control (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 1-piece (pc) 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: (b)(4) manufacturing site: (b)(4).
 
Event Description
To date no additional patient or event details have been received.
 
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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 Key9737377
MDR Text Key180392513
Report Number9618003-2020-02283
Device Sequence Number1
Product Code EZQ
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
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
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date04/05/2023
Device Model Number125353
Device Lot Number8C02898
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Initial Date Manufacturer Received 01/30/2020
Initial Date FDA Received02/21/2020
Supplement Dates Manufacturer Received11/28/2023
Supplement Dates FDA Received11/30/2023
Was Device Evaluated by Manufacturer? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage A
Patient Sequence Number1
Patient SexMale
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