MAUDE Adverse Event Report: CONVATEC DOMINICAN REPUBLIC INC NATURA; NOT APPLICABLE

Model Number 402204

Device Problem Malposition of Device (2616)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Based on the available information, this event is deemed to be a reportable malfunction.An investigation was performed to determine the root cause associated with the 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 (b)(4).The cause and effect investigation was performed.  it was determined that the following probable root causes and opportunities were identified: machinery is the root cause of this incident.  it is concluded that all the machinery/ tooling items complied when compared against drawing specifications, however due to the demands of the process, these tooling require a dimension modification to reduce the variability of the process.Observations include:  misalignment of the wafer loading pins, misalignment of the upper wafer loading plate and fixation of the upper wafer loading plate and lower wafer loading plate.Actual testing method of (random hourly sampling) may not effectively capture the defects prior to packaging, it is suggested the implementation of a continuous testing method to anticipate to all of the peaks.A certification of the operators who have direct influence due to the ¿flange/wafer loading¿ process in operations, 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.Actions will be taken for each factor and will be summarized on a corrective action / preventive actions (capa) plan.The investigation associated with this event is approved and complete.  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: (b)(4).

Event Description

It was reported hole is not centered correctly so the edges overlap with the sticky surface, which makes it very difficult to attach the wafer to the skin.No photo was provided.

Manufacturer Narrative

Common device name: protector, ostomy.Exe; exempt.A batch record review was carried out on 10/30/2018 for the affected lot number 8g01612.The affected lot number was manufactured following the applicable procedures, all the testing scheme comply with the applicable documentation, the line clearance was executed per standard operating procedures and the results were documented.The material complies with specifications and other procedures were revised.The results are satisfactory.No photo/ no sample is available for evaluation related to the reported problem.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.It was determined the following root causes and opportunities: 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.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.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 procedural instruction specifications, however due to the demands of the process, these tooling require a dimension modification to reduce the variability of the process.The following observations are: 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 is different.This issue will be monitored through the post market product monitoring review process.No additional information has been provided to date.Should additional information become available a follow-up report will be submitted.Reporting site: (b)(4).Manufacturing site: (b)(4).

Event Description

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

• Brand Name: NATURA
• Type of Device: NOT APPLICABLE
• Manufacturer (Section D): CONVATEC DOMINICAN REPUBLIC INC; km 18.5 parque industrial; itabo, s.a. haina; san cristobal
• MDR Report Key: 8037733
• MDR Text Key: 126381004
• Report Number: 9618003-2018-02580
• Device Sequence Number: 1
• Product Code: EXD
• Combination Product (y/n): N
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/27/2023
• Device Model Number: 402204
• Device Lot Number: 8G01612
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 10/31/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1