MAUDE Adverse Event Report: CONVATEC DOMINICAN REPUBLIC INC L3O0200 - NATURA; PROTECTOR, OSTOMY

Model Number	411801
Medical Device Problem Code	Material Disintegration (1177)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
The end user reported that when she tried to mold one wafer from the sample pack of three, the moldable portion of wafer mass crumbled.She did not used the product.No photograph is available at this time.
Additional Manufacturer Narrative
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 reporting site: 1049092.Manufacturing site: 9618003.
Event or Problem Description
To date no additional patient or event details have been received.
Additional 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 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 0k00503 was manufactured on 08 oct 2020, in ats #2 line, with a total of (b)(4) market units (mkus).The compliance engineer performed a batch record review on 27 sep 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 identification (id) 1222273 and manufacturing order (b)(4).The production process, in-process control, testing results and packaging of products was run according to the process instruction (pi).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 27 sep 2023, compliance engineer ran a query in database in order to verify the complaints reported for the 0k00503 lot for the malfunction ¿skin barrier does not mold around stoma (e.G too stiff, too dry, tears /crumbles when molding) at point of application¿ and as result, an additional complaint was found reported by the same customer.No other complaints reported by different customers were found.Historical nonconformance review: on 27 sep 2023, compliance engineer ran a query in database looking for any in process nonconformance / corrective action / preventive actions (capa) (s) associated to the malfunction "skin barrier does not mold around stoma (e.G too stiff, too dry, tears /crumbles when molding) at point of application¿ for the lot number 0k00503 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: br31-144 section 3.0 ¿dimensional verification and visual inspection¿: ¿ frequency: 24 times per shift (3 per hour) ¿ sample quantity: 1 piece per head and 3 per hour ¿ acceptance criteria: accept = 0 | reject = 1 defect rate analysis: there have only been 4 defective parts confirmed to date from a lot size of 4200 products.This represents a defect rate of only 0.09%, which is well within an appropriate acceptable quality level (aql) for this defect which should be 0.25% based on our standard operating procedure (sop) ¿quality inspection 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 acceptable quality level (aql) of 0.25.This issue certainly appears to be an isolated incident, but more importantly to date, it is well within our accepted acceptable quality level (aql) level for this type of failure mode or defect.Conclusions: no objective evidence were 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 for lot 0k00503 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 ¿skin barrier does not mold around stoma (e.G too stiff, too dry, tears /crumbles when molding) at point of application¿.No additional complaints were reported for lot affected related to the malfunction ¿skin barrier does not mold around stoma (e.G too stiff, too dry, tears /crumbles when molding) at point of application¿.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.

• Brand Name: L3O0200 - NATURA
• Common Device Name: 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: 15189586
• Report Number: 9618003-2022-04699
• Device Sequence Number: 14955815
• Product Code: EXE
• UDI-Device Identifier: 00768455187010
• UDI-Public: 00768455187010
• Combination Product (Y/N): N
• Initial Reporter State: PA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 10/07/2025
• Device Model Number: 411801
• Device Lot Number: 0K00503
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/14/2022
• Supplement Date Received by Manufacturer: 12/19/2023
• Initial Report FDA Received Date: 08/09/2022
• Supplement Report FDA Received Date: 12/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/08/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown