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

Model Number	421039
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: patient information: (b)(6).Based on the available information, this event is deemed to be a reportable malfunction.Photograph, video and/or physical sample evaluation: there are photographs associated with this case and in these, the reported defect can be seen.No unused return sample was expected.Batch record revision results: lot 3f00128 was manufactured 01/jun/2023, in ffs#1 line, with a total of (b)(4) market units (mkus).The complaints investigator performed a batch record review on 13/sep/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) 1709734 and manufacturing order (b)(4).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 13/sep/2024, complaints investigator ran a query in database in order to verify the complaints reported for the 3f00128 lot for the malfunction ¿skin barrier starter hole is defective (e.G misalignment or off center), leakage may occur (moldable only)¿ defect and no additional complaints were identified.Historical nonconformance review: on 13/sep/2024, complaints investigator ran a query in database looking for any in process nonconformance / corrective action / preventive actions (capa) (s) associated to the malfunction ¿skin barrier starter hole is defective (e.G misalignment or off center), leakage may occur (moldable only)¿ defect for the lot number 3f00128 and as result, no nonconformance / capa (s) for this malfunction were generated during the manufacturing process of the referenced lot.Test method (tm)-017 "disc appearance (collar)": frequency: 6 samples per hour (48 samples per shift), sample quantity: 48 samples per shift, acceptance criteria: accept = 0 | reject = 1.Defect rate analysis: there have only been 1 defective parts confirmed to date from a lot size (b)(4) products.This represents a defect rate of only (b)(4), which is well within an appropriate acceptable quality level (aql) for this defect which should be 0.25% based on our procedure.In addition, all of 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 0.25.To date, it is well within our accepted aql level for this type of failure mode or defect.Conclusions: as photographs were available for this complaint issue, they were evaluated and as a result, the reported malfunction for the observed product was confirmed, however, after performing the defect rate analysis for this issue, it was observed that the quantity of reportedly affected products is within the appropriate aql for this defect.A batch record review was completed and 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.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 or Problem Description
The nurse reported that one wafer from a sample package had starter hole off centered.The product was not used.The photographs depicting the issue were received from the complainant.

• Brand Name: 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 27409 ; 3365424679
• MDR Report Key: 20277231
• Report Number: 9618003-2024-03010
• Device Sequence Number: 8013260
• Product Code: EXE
• UDI-Device Identifier: 00768455133819
• UDI-Public: 00768455133819
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/04/2024

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: Health Professional
• Device Model Number: 421039
• Device Lot Number: 3F00128
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/04/2023
• Initial Report FDA Received Date: 09/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/01/2023
• 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