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

Model Number 411658

Device Problems Fluid/Blood Leak (1250); Leak/Splash (1354); Malposition of Device (2616)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Device 11 of 20.The product is beyond its expiration date 10th november 2022.Expiry date is not on all ostomy products, therefore end user will not be aware of using expired product.(b)(6).Complainant country: sweden.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 that starter hole of the wafers was not centered.The product was used and caused leakage.The photographs depicting the issue were received from complainant.

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 7l04254 was manufactured on 11/dec/2017, in ats #1 manufacturing line, with a total of (b)(4) market units (mkus).Complaint investigator performed a batch record review on 14/dec/2022, 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, system application product (sap) material identification 1263353 and manufacturing order (b)(4).Therefore, no discrepancy related to this issue were found within the documentation.Complaint data analysis: on 14/dec/2022, complaint investigator performed a search of complaints into database system for lot number 7l04254.As a result, a total of 03 complaints were found and 02 are related to the same malfunction code of this investigation.Photograph, video and/or physical sample evaluation: five photographs associated with this case were received and no unused return sample was expected.  conclusion summary of the related event: a complaint search performed in database system by manufacturing date for the ¿starter hole off center or misaligned¿ failure mode for ats#1 and ats#2 manufacturing lines shows a decreasing trend from jun 2019 to date (cut off 30/sep/ 2020).Based on the preliminary investigation, the most probable cause for the cases related to manufacturing process in the ats#1 and ats#2 manufacturing lines is related to machine condition.As part of the nonconformance report (ncr) actions were taken for this failure mode, which were the main factors for the reduction in the quantity of complaints per month.In addition, the investigations (rci¿s) records were carried out and actions were taken for the off-center failure mode in the convex two (2) piece (ostomy) and convex two (2) piece (wct) bulks manufacturing lines.Furthermore, a nonconformance search was performed in database system from 2018 to 30/sep/ 2020, for the ¿starter hole off center or misaligned¿ failure mode for ats#1 and ats#2 manufacturing lines and as a result, no events related to this malfunction were found.Moreover, the following quality and manufacturing controls are currently in place in the ats#1 & ats#2, according to the product instructions and test methods, which contribute directly to the detection activities: manufacturing process instructions (pi - ats1 assembly and packaging / pi - ast2 assembly and packaging).Visual inspection to completed product 100% of units.Testing and inspection log ¿ dimensional verification and visual inspection looking for collar concentricity six samples at the beginning of the batch and each 1 hour.Quality test methods (tm- visual nonconformities laminated adhesive products / tm- pouch nonconformities).A quality notification was given to the quality and manufacturing personnel of the ats#1, ats#2, convex two (2) piece (ostomy) and convex two (2) piece (wct) manufacturing lines, to make them aware of the new complaints received for this failure mode (refer to attachment #3 and attachment #5 of this ncr).For everything explained above, no additional actions are required.This issue will be monitored through the post market product monitoring review process, standard operating procedure (sop).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.

Event Description

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

• Brand Name: ESTEEM SYNERGY
• Type of Device: PROTECTOR, OSTOMY
• Manufacturer (Section D): CONVATEC DOMINICAN REPUBLIC INC; km 18.5 parque industrial; itabo, s.a. haina; san cristobal 91000 ; DR 91000
• Manufacturer (Section G): CONVATEC DOMINICAN REPUBLIC INC; km 18.5 parque industrial; itabo, s.a. haina; san cristobal 91000 ; DR 91000
• Manufacturer Contact: pamela meadows ; 7815 national service road; suite 600; greensboro, NC ; 3365424679
• MDR Report Key: 15968074
• MDR Text Key: 308528202
• Report Number: 9618003-2022-05402
• Device Sequence Number: 1
• Product Code: EXE
• UDI-Device Identifier: 10768455117342
• UDI-Public: 00768455186983
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 11/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/10/2022
• Device Model Number: 411658
• Device Lot Number: 7L04254
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 12/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/11/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female