NATURA
Report
- Report Number
- 9618003-2023-00760
- Event Type
- Malfunction
- Date Received
- July 3, 2023
- Report Date
- June 8, 2023
- Manufacturer
- CONVATEC DOMINICAN REPUBLIC INC
- Product Code
- EXE
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- 003
Narratives
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: RETURNED SAMPLE EVALUATION: NO PHOTOGRAPH ASSOCIATED WITH THIS CASE WAS RECEIVED FOR EVALUATION. BATCH RECORD REVIEW: THE LOT 2J02123 WAS MANUFACTURED ON 30/SEP/2022 CONVEX 2-PIECE (PC) MANUFACTURING LINE, WITH A TOTAL OF (B)(4) MARKET UNITS. COMPLAINT INVESTIGATOR PERFORMED A BATCH RECORD REVIEW ON 21/JUL/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 1052420 AND MANUFACTURING ORDER (B)(4). THE BATCH RECORD REVIEW SUPPORTS THAT THERE WERE NO DISCREPANCIES RELATED TO THE ISSUE REPORTED. INVESTIGATION SUMMARY: THIS ISSUE IS RELATED TO OFF CENTER ISSUES. THE SCOPE OF THIS INVESTIGATION COVERS ALL PRODUCT FAMILY MANUFACTURED IN CONVEX 2PC LINE. THIS COMPLAINT HAS BEEN EVALUATED FOR MDR REPORTABILITY USING WI-0361 MDR PROCEDURE WORK INSTRUCTION. THE 30-DAY MDR REPORTABILITY DECISION FOR THIS COMPLAINT IS YES. THERE WAS NO HARM REPORTED WITH THIS COMPLAINT. THE COMPLAINT AS DESCRIBED HAS BEEN REVIEWED AND DOES NOT REPRESENT A THREAT TO PUBLIC SAFETY AND THEREFORE DOES NOT WARRANT A 5-DAY REPORT TO THE FDA PER 21 CFR PART 803. THIS EVENT IS CONSIDERED SYSTEMIC BASED ON THE INCREASE OF COMPLAINTS REPORTED FROM 01/JAN/2022 TO 31/DEC/2022, ADDITIONAL ELEVEN (11) HARM ALERT WERE REPORTED BY THREE DIFFERENT COMPLAINANTS AND DIFFERENT PERIOD, IN ADDITION IT WAS IDENTIFIED A NONCONFORMANCE REPORT BEFORE THIS INVESTIGATION PROCESS. BASED ON THAT, ACTIONS WILL BE TAKEN TO MITIGATE THE FAILURE MODE REPORTED. REFER TO THE PROCESS INSTRUCTION (PI) AND MANUFACTURING LINES IMPACTED IN THIS NONCONFORMANCE BELOW: CONVEX 2-PIECE (PC) (PROCESS INSTRUCTION (PI) CONVEX 2-PIECE (PC) WAFER SUB-ASSEMBLY MACHINE 2 COLLARING OPERATIONS). AFTER 6 METHODOLOGIES (MS) ANALYSIS WAS IDENTIFIED. CORRECTIVE AND PREVENTIVE ACTIONS WILL BE TAKEN FOR EACH OF THE CAUSES IDENTIFY FOR PROBLEM SOLUTION. REFER TO CORRECTIVE ACTION / PREVENTIVE ACTIONS (CAPA) PLAN RECORD IN DATABASE. THE INVESTIGATION HAS BEEN APPROVED AND IS COMPLETE. NO ADDITIONAL ACTION IS REQUIRED, AND THIS COMPLAINT WILL BE CLOSED. 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.
INITIAL 4 OF 10. (B)(6). 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
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
IT WAS REPORTED BY A MEDICAL SUPPLIER, THAT A CLIENT SAID THAT THE COMPANY'S KNOWN PRE-CUT OPENING WAFER'S STARTER HOLE WAS NOT IN THE CENTER WHICH CAUSED TROUBLE. THE PRODUCT WAS USED BY THE PATIENT AND NO HARM REPORTED. NO PHOTO WAS AVAILABLE AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1255346 | NATURA | PROTECTOR, OSTOMY | EXE | CONVATEC DOMINICAN REPUBLIC INC | 402205 | 2J02123 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |