| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NATURA | PROTECTOR, OSTOMY | CONVATEC DOMINICAN REPUBLIC INC | EXE | 413179 | 8E04641 | N | N | ||||
| 700497 | NATURA | PROTECTOR, OSTOMY | CONVATEC DOMINICAN REPUBLIC INC | EXE | 413179 | 8E04641 | N | N |
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2019-11-29 | 0 |
Patient 1
MDR 9618003-2019-14882/ DEVICE 19 OF 20. 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. (B)(4).
Patient 1
THE END USER REPORTED THAT 20 WAFERS OUT OF 2 BOXES OF 10 WAFERS HAD AN OFF CENTERED STARTER HOLE. THE PRODUCTS WERE NOT USED. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient 0
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient 0
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. BATCH RECORD REVIEW LOT 8E04641 WAS MANUFACTURED ON 06/04/2018 IN THE CONVEX 2 PIECE (PC) BUILDING 8, WITH A TOTAL OF (B)(4) MARKET UNITS. COMPLAINT INVESTIGATOR ID 5173 PERFORMED A BATCH RECORD REVIEW ON 11/20/2019 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, UNDER INTERNATIONAL COMMODITY CODE (ICC) 413179 SYSTEM APPLICATION PRODUCT (SAP) MATERIAL IDENTIFICATION (ID) 1161268 AND MANUFACTURING ORDER (B)(4). THE BATCH RECORD REVIEW SUPPORTS THAT THERE WERE NO DISCREPANCIES RELATED TO THE ISSUE REPORTED. RETURNED SAMPLE EVALUATION: NO PHOTOGRAPH ASSOCIATED WITH THIS CASE AND NO UNUSED RETURN SAMPLE WAS EXPECTED. SUMMARY OF THE RELATED EVENT: THE PURPOSE OF THIS INVESTIGATIONS WAS TO DETERMINE THE ROOT CAUSE ASSOCIATED INVESTIGATION WAFER DISC DECENTRALIZATION, COMPLAINT MALFUNCTION (SKIN BARRIER STARTER HOLE IS DEFECTIVE, E.G. MISALIGNMENT OR OFF CENTER, LEAKAGE MAY OCCUR), FOR LOTS MANUFACTURED IN CONVEX 2 PC BUILDING 8, HAINA, D.R. AFTER THE USE OF THE 6 M?S METHODOLOGY TO DOCUMENT INVESTIGATION FINDINGS, EXPLORE AND ANALYZE PROBABLE CAUSES, IT WAS DETERMINED THE FOLLOWING ROOT CAUSES AND OPPORTUNITIES: 1. METHOD OPPORTUNITY: DUE TO THE FACT THAT THE OCCURRENCE OF THIS FAILURE MODE WAS NOT CONSTANT, IT HAS PEAKS OF OCCURRENCE DURING THE PROCESS, IT WAS OBSERVED THAT THE ACTUAL TESTING METHOD (RANDOM HOURLY SAMPLING) MIGHT NOT CAPTURED EFFECTIVELY THE DEFECTS PRIOR TO PACKAGING, SO IT WAS SUGGESTED THE IMPLEMENTATION OF A CONTINUOUS TESTING METHOD TO ANTICIPATE TO ALL OF THE PEAKS. 2. MANPOWER OPPORTUNITY: A CERTIFICATION OF THE OPERATORS WHO HAVE DIRECT INFLUENCE DUE TO THE ?FLANGE/WAFER LOADING? PROCESS IN THE OPERATION THEY ARE EXECUTING SHOULD BE CONSIDERED IN ORDER TO REDUCE THE LEARNING CURVE EFFECT IN PROCESS AND GUARANTEE THE TRAINING EFFECTIVENESS. THIS SHOULD BE PERFORMED IN CONJUNCT WITH THE QUALITY INSPECTOR, PROCESS ENGINEER OF SUCH LINE AND THE SUPERVISOR. 3. MACHINE: IT WAS CONSIDERED THAT DUE TO THE OBSERVATIONS REGISTERED, MACHINERY WAS THE ROOT CAUSE OF THIS INCIDENT. IT WAS CONCLUDED THAT ALL THE MACHINERY/ TOOLING ITEMS COMPLIED WHEN COMPARED AGAINST DRAWING AND PROCEDURE INSTRUCTION (PI) SPECIFICATIONS, HOWEVER DUE TO THE DEMANDS OF THE PROCESS, THESE TOOLING REQUIRE A DIMENSION MODIFICATION TO REDUCE THE VARIABILITY OF THE PROCESS. LISTED BELOW ARE THE OBSERVATIONS. MISALIGNMENT OF THE WAFER LOADING PINS. MISALIGNMENT OF THE UPPER WAFER LOADING PLATE. FIXATION OF THE UPPER WAFER LOADING PLATE AND LOWER WAFER LOADING PLATE. ACTIONS WILL BE TAKEN FOR EACH FACTOR AND ARE GOING TO BE SUMMARIZED ON CORRECTIVE ACTION / PREVENTIVE ACTIONS (CAPA) PLAN. ACTIONS COVERED IN THIS INVESTIGATION WILL BE IMPLEMENTED IN CONVEX 2 PC BUILDING 8 INSIDE CONVATEC D.R., EXCEPT FOR AUTOMATIC CONVEX 2 PC, BECAUSE THE DESIGN AND FUNCTIONING OF THIS MACHINE WAS DIFFERENT. 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.