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

Model Number 402203

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.Fda registration number: (b)(4).

Event Description

It was reported the starter hole was off center in 28 wafers.The product was not used.No photos were provided.

Manufacturer Narrative

D.1: brand name- natura, d.2: common device name ¿ protector, ostomy, d.2b: product code ¿ exe, g.5: 510k- exempt.A batch record review was carried out on (b)(6)2018, for the affected lot number 7k03422.The lot 7k03422 was manufactured following the applicable procedures, all the testing scheme comply with the applicable documentation, the line clearance was executed per standard operating procedure and the results were documented.The material complies with the bill of materials, process instructions, packaging and labeling, design specifications, test method, material specifications, and other procedures were revised and the results are satisfactory.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.To date no additional information has been received.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: 8141739
• MDR Text Key: 129891465
• Report Number: 9618003-2018-03783
• 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,other
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Expiration Date: 10/20/2022
• Device Model Number: 402203
• Device Lot Number: 7K03422
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 12/21/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1