MAUDE Adverse Event Report: CONVATEC DOMINICAN REPUBLIC INC ESTEEM+; POUCH, COLOSTOMY

Model Number 416740

Device Problems Malposition of Device (2616); Positioning Problem (3009)

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

Event Type  malfunction  

Manufacturer Narrative

Device 17 of 20.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's caregiver reported the starter hole of twenty appliances was off centered.Additionally, caregiver stated that five pouches from the box were worn and had fifteen more were off centered but not worn, from two market units with same lot.Additionally, it was also mentioned that end user had noticed several weeks ago that the pouches were not sticking to her skin, and she had not changed any part of her application routine.Also, her wear time was reduced from three days to less than one day, and she denied any leakage of stool.No photo is available at this time.

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 h10: investigation summary an investigation was completed for this complaint by the assigned manufacturing site investigation team.The complaint summary of this investigation required rework.A corrective actions/preventive actions (capa) was raised and an updated/corrected investigation summary has been completed in accordance with assigned capa.A supplemental mdr is being submitted to document the completion of investigation rework and final investigation; the complaint record will proceed to closure.Photograph, video and/or physical sample evaluation: no photographs associated with this case were received and no unused return sample was expected.Batch record revision results: lot 1k04031j was manufactured on 11/26/2021, in convex 1 pc line, with a total of(b)(4) mkus.The compliance engineer performed a batch record review on 02/oct/2023, 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 id 1703550 and manufacturing order (b)(4).The production process, in-process control, testing results and packaging of products was run according to the process instruction and recorded in br31-146 ver.7.0.Review of the batch record showed that all relevant tests required during the manufacturing process and final product release had been fulfilled and met the requirements.No discrepancy related to this issue were found within the documentation.Historical complaints review: on 02/oct/2023, compliance engineer ran a query in database in order to verify the complaints reported for the 1k04031j lot for the malfunction code ¿skin barrier starter hole is defective (e.G misalignment or off center), leakage may occur (pre-cut only)¿ and as result, no additional type 2 complaints were identified during this search as per work instruction.Historical nonconformance review: on 02/oct/2023, compliance engineer ran a query in database looking for any in process nonconformance / corrective action/preventive action (capa) (s) associated to the malfunction code ¿skin barrier starter hole is defective (e.G misalignment or off center), leakage may occur (pre-cut only)¿ for the lot number 1k04031j and as result, no nonconformance / capa (s) for this malfunction code were generated during the manufacturing process of the referenced lot.Current quality controls: based on the process instruction, the following tests are performed in the manufacturing lines, in order to identify this failure mode in our manufacturing process: pd31-146 ¿dimensional wafer ctq¿: ¿ frequency: 16 pouches per turn (2 pouches per hour) ¿ sample quantity: 16 pouches per turn (first piece at start) ¿ acceptance criteria: accept = 0 | reject = 1 defect rate analysis: there have only been 20 defective parts confirmed to date from a lot size of 5920 products.This represents a defect rate of only 0.34%, which is well within an appropriate acceptable quality level (aql) for this defect which should be 2.5% based on our pd31-146 ver.2.0 ¿convex 1 pc sampling plan¿.In addition, all of the in-process testing on this lot did not find a single defective pouch, which confirms that the lot is unlikely to breach an aql of 2.5.This issue certainly appears to be an isolated incident, but more importantly to date, it is well within our accepted aql level for this type of failure mode or defect.Conclusions: the review of the batch record for lot 1k04031j showed that all relevant tests required during the manufacturing process and final product release had been fulfilled and met the requirements, all applicable manufacturing and quality processes were followed, and no discrepancies or deviations were recorded.No changes to the end-to-end manufacturing process or components used during assembly of the batch were made.No nonconformity has been registered during the manufacturing process of the affected lot for the malfunction code ¿skin barrier starter hole is defective (e.G misalignment or off center), leakage may occur (pre-cut only)¿.No additional complaints were reported for lot affected related to the malfunction code ¿skin barrier starter hole is defective (e.G misalignment or off center), leakage may occur (pre-cut only)¿.Based on this, no negative trend was identified.Based on preliminary investigation results, there is no objective evidence that other products from this lot are impacted, and the issue appears to be isolated.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.

Event Description

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

• Brand Name: ESTEEM+
• Type of Device: POUCH, COLOSTOMY
• 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: 16251812
• MDR Text Key: 308580272
• Report Number: 9618003-2023-00182
• Device Sequence Number: 1
• Product Code: EZQ
• UDI-Device Identifier: 00768455188499
• UDI-Public: 00768455188499
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 416740
• Device Lot Number: 1K04031J
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 10/04/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/26/2021
• 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