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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 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.
 
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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 Key8790366
MDR Text Key151025533
Report Number9618003-2019-04701
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 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 Date11/17/2022
Device Model Number175777
Device Lot Number7L02692
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 Received07/15/2019
Supplement Dates Manufacturer Received10/16/2023
Supplement Dates FDA Received10/16/2023
Was Device Evaluated by Manufacturer? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage A
Patient Sequence Number1
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