NATURA
Report
- Report Number
- 9618003-2023-00371
- Event Type
- Malfunction
- Date Received
- April 28, 2023
- Date of Event
- April 4, 2023
- Report Date
- April 4, 2023
- Manufacturer
- CONVATEC DOMINICAN REPUBLIC INC
- Product Code
- EXE
- UDI-DI
- 00768455124008
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL
- Reporter Occupation
- OTHER
- Health Professional
- N
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. 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 2K00199 WAS MANUFACTURED ON 10/05/2022, 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 ID 1703890 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) AND RECORDED IN BR31-144 VER. 5.0. 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 27/SEP/2023, COMPLIANCE ENGINEER RAN A QUERY IN DATABASE IN ORDER TO VERIFY THE COMPLAINTS REPORTED FOR THE 2K00199 LOT FOR THE MALFUNCTION CODE ¿SKIN BARRIER DOES NOT MOLD AROUND STOMA (E.G TOO STIFF, TOO DRY, TEARS /CRUMBLES WHEN MOLDING) AT POINT OF APPLICATION¿ AND AS RESULT, NO ADDITIONAL TYPE 2 COMPLAINTS WERE IDENTIFIED DURING THIS SEARCH AS PER WORK INSTRUCTIONS. HISTORICAL NONCONFORMANCE REVIEW: ON 27/SEP/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 DOES NOT MOLD AROUND STOMA (E.G TOO STIFF, TOO DRY, TEARS /CRUMBLES WHEN MOLDING) AT POINT OF APPLICATION¿ FOR THE LOT NUMBER 2K00199 AND AS RESULT, NO NONCONFORMANCE / CORRECTIVE ACTION/PREVENTIVE ACTION (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 1 DEFECTIVE PART CONFIRMED TO DATE FROM A LOT SIZE OF 23000 PRODUCTS. THIS REPRESENTS A DEFECT RATE OF ONLY 0.004%, 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 2K00199 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 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 CODE ¿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.
H6: IMDRF HEALTH IMPACT CODE HAS BEEN SELECTED AS F27 SINCE THE EVENT OCCURRED PRIOR TO USE ON PATIENT. 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: (B)(4). MANUFACTURING SITE: 9618003.
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
THE END USER¿S WIFE REPORTED THAT THE MASS WAS DRIED OUT AND BRITTLE AS SHE ATTEMPTED TO MOLD THE MOLDABLE HOLE OF ONE WAFER FROM THE SAMPLE PACK OF THREE. SHE ADVISED THIS MADE THE PRODUCT UNUSABLE. ALSO, STATED THAT THE USUAL WEAR TIME WAS THREE DAYS. NO PHOTO IS AVAILABLE AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 489113 | NATURA | PROTECTOR, OSTOMY | EXE | CONVATEC DOMINICAN REPUBLIC INC | 413418 | 2K00199 | 00768455124008 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |