MAUDE Adverse Event Report: CONVATEC DOMINICAN REPUBLIC INC NATURA; PROTECTOR, OSTOMY

Model Number 404594

Device Problem Material Separation (1562)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

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 "six wafers in box with mass being slightly off center exposing a small area of the flange skirt".

Manufacturer Narrative

(b)(6).Batch record review: lot 7f05062 was manufactured on 07/04/2017, in the convex 2 pc line with a total of (b)(4) ea.Compliance engineer id 6054 performed a batch record review on 10/02/2020, 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 404594, sap material id 1156502 and manufacturing order 1352878.The batch record review supports that there were no discrepancies related to the issue reported.The product was manufactured under device specification ds10-178.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 pi21-140.The process requirements results were documented in the manufacturing records mr21-140.Returned sample evaluation: there is one (1) photographs associated with this case and in this, the reported defect can be seen.No unused return sample was expected.Investigation conclusion the purpose of this investigations was to determine the root cause associated investigation wafer disc decentralization, complaint malfunction code ost-pmc1.8 (skin barrier starter hole is defective, e.G.Misalignment or off center, leakage may occur), for lots manufactured in convex 2 pc building 8, haina, d.R.After the use of the 6 m¿s methodology to document investigation findings, explore and analyze probable causes, it was determined the following root causes and opportunities: method opportunity: due to the fact that the occurrence of this failure mode is not constant, it has peaks of occurrence during the process, it is observed that the actual testing method (random hourly sampling) may not captured effectively the defects prior to packaging, so it is suggested the implementation of a continuous testing method to anticipate to all of the peaks.Manpower opportunity: a certification of the operators who have direct influence due to the ¿flange/wafer loading¿ process in the operation they are executing should be considered in order to reduce the learning curve effect in process and guarantee the training effectiveness.This should be performed in conjunct with the quality inspector, process engineer of such line and the supervisor.Machine: it is considered that due to the observations registered, machinery is the root cause of this incident.It is concluded that all the machinery/ tooling items complied when compared against drawing and pi21-139 rev 10.0 specifications, however due to the demands of the process, these tooling require a dimension modification to reduce the variability of the process.Listed below are the observations.Misalignment of the wafer loading pins.Misalignment of the upper wafer loading plate.Fixation of the upper wafer loading plate and lower wafer loading plate.The automatic convex 2 pc in the 29 building was also evaluated for decentralization issues, but due to the fact that the design and functioning of this machine is different, the root cause identified for this investigation do not apply to the automatic convex 2 pc building 29.The differences rely on a different mechanism, instead of a manual loading station the automatic convex 2 pc has a pick n¿ place mechanism to handle the raw material through the production.There are no manual loading tooling in this machine, so the failure mode conditions needed to replicate it couldn¿t be met.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: NATURA
• Type of Device: PROTECTOR, OSTOMY
• Manufacturer (Section D): CONVATEC DOMINICAN REPUBLIC INC; km 18.5 parque industrial; itabo, s.a. haina; san cristobal
• MDR Report Key: 8010965
• MDR Text Key: 125649253
• Report Number: 9618003-2018-02877
• Device Sequence Number: 1
• Product Code: EXE
• 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
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/03/2022
• Device Model Number: 404594
• Device Lot Number: 7F05062
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 10/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1