MAUDE Adverse Event Report: CONVATEC DOMINICAN REPUBLIC INC

Model Number 404592

Device Problems Nonstandard Device (1420); Malposition of Device (2616)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Device 1 of 10.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 reported 10 unused wafers that had an off-centered moldable starter hole.No photo is available at this time.

Event Description

To date no additional patient or event details have been received.

Manufacturer Narrative

Additional information - this emdr is being submitted to include the below: h6 - investigation results under imdrf cause investigation code, imdrf investigation findings, imdrf cause conclusions.Batch record review: lot 8e05049 was manufactured on 06/08/2018, in the convex 2 piece (pc) line with a total of (b)(4) market units.Complaint investigator performed a batch record review on 11/21/2019, 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) 404592, 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.Returned sample evaluation: there are no photographs associated with this case and no unused return sample was expected.Summary of the related event: 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: method opportunity: due to the fact that the occurrence of this failure mode was not constant, it has peaks of occurrence during the process, it was observed that the actual testing method (random hourly sampling) might not captured effectively the defects prior to packaging, so it was 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 was considered that due to the observations registered, machinery was the root cause of this incident.It was concluded that all the machinery/ tooling items complied when compared against drawing and procedure instruction (pi) 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.Actions will be taken for each factor and are going to be summarized on corrective action / preventive actions (capa) plan.Actions covered in this investigation will be implemented in convex 2 pc building 8 inside convatec d.R., except for automatic convex 2 pc, because the design and functioning of this machine was different.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.

• 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: 9334725
• MDR Text Key: 174480824
• Report Number: 9618003-2019-08512
• Device Sequence Number: 1
• Product Code: EZQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/07/2023
• Device Model Number: 404592
• Device Lot Number: 8E05049
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 07/15/2022
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1