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

Model Number 421023

Device Problem Malposition of Device (2616)

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

Event Type  malfunction  

Manufacturer Narrative

Mdr 9618003-2024-00128 / device 3 of 3 complainant state: akita complainant country: japan name of affiliation: crosswill medical based on the available information, this event is deemed to be a reportable malfunction.Photograph, video and/or physical sample evaluation: ¿ no photograph associated with this case was received.No return sample has been received for this complaint.Batch record revision results: lot 3b02548 was manufactured on 21/mar/2024, in 23a line, with a total of 816 market units (mkus).The complaint investigator performed a batch record review on 26/jan/2024, 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 (id) 1728760 and manufacturing order 1668308.The production process, in-process control, testing results and packaging of products was run according to the process instruction (pi) pi31-028 and recorded in br31-063.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 26/jan/2024, the complaint investigator ran a query in database in order to verify the complaints reported for 3b02548 lot for the malfunction "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 (wi).Historical nonconformance review: on 26/jan/2024, the complaint investigator ran a query in database looking for any in process nonconformance / capa (s) associated to the malfunction "skin barrier starter hole is defective (e.G misalignment or off center), leakage may occur (pre-cut only)¿ for the lot number 3b02548 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 (pi), the following tests are performed in the manufacturing lines, in order to identify this failure mode in our manufacturing process: tm-017 "visual nonconformities - laminated adhesive products" - method 2: ¿ frequency: hourly ¿ sample quantity: 10 pouches ¿ acceptance criteria: accept = 0 | reject = 1 defect rate analysis: there have only been 3 defective parts confirmed to date from a lot size of 8,160 products.This represents a defect rate of only 0.037% which is well within an appropriate acceptable quality level (aql) for leakage which should be 1.0% based on our dr-sop-0063 "quality inspection plan".In addition, all the in-process testing on this lot did not find a single defective unit, which confirms that the lot is unlikely to breach an aql of 1.0 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: no objective evidence was received such as a photo or sample, for this reason, we cannot conclude that the product does not meet specifications.The review of the batch record 3b02548 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 nonconformity has been registered during the manufacturing process of the affected lot for the malfunction "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 "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.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.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

The distributor reported that wafer had off centered starter hole.The product was not used.No photo was available at this time.

• 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: 18639640
• MDR Text Key: 336056571
• Report Number: 9618003-2024-00128
• Device Sequence Number: 1
• Product Code: EZQ
• 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,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 421023
• Device Lot Number: 3B02548
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/11/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/21/2023
• 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