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

Model Number	413185
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
It was reported 10 wafers in the box had off center mass.No harm reported photos depicting the reported complaint issue were provided by the complainant.
Event or Problem Description
To date no additional patient or event details have been received.
Additional Manufacturer Narrative
Investigation summary: batch record review: lot 8a04962 was manufactured on 01/26/2018 in the convex 2pc line in the 29 building, with a total of (b)(4) market units.Complaint investigator performed a batch record review on 08/13/2019 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) 413185 system application product (sap) material id (b)(4) and manufacturing order (b)(4).The batch record review supports that there were no discrepancies related to the issue reported.Returned sample evaluation: photos related to the reported problem are available for evaluation.Investigation conclusion: the purpose of this investigations was to determine the root cause associated investigation wafer disc decentralization, complaint malfunction (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: 1.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.2.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.3.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 process instruction (pi) 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 is no manual loading tooling in this machine, so the failure mode conditions needed to replicate it couldn¿t be met.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.

• Brand Name: NATURA
• Common Device Name: PROTECTOR, OSTOMY
• 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: 8527063
• Report Number: 9618003-2019-02763
• Device Sequence Number: 2384438
• Product Code: EXE
• UDI-Device Identifier: 00768455124558
• UDI-Public: 00768455124558
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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

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: 01/25/2023
• Device Model Number: 413185
• Device Lot Number: 8A04962
• 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): Thirty-Day
• Initial Date Received by Manufacturer: 04/01/2019
• Supplement Date Received by Manufacturer: 08/04/2023
• Initial Report FDA Received Date: 04/18/2019
• Supplement Report FDA Received Date: 08/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Male