NATURA
Report
- Report Number
- 9618003-2024-02430
- Event Type
- Injury
- Date Received
- July 23, 2024
- Report Date
- June 28, 2024
- Manufacturer
- CONVATEC DOMINICAN REPUBLIC INC
- Product Code
- EXH
- UDI-DI
- 00768455182787
- PMA / PMN Number
- EXEMPT
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A SERIOUS INJURY. 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.
ADDITIONAL INFORMATION - THIS EMDR IS BEING SUBMITTED TO INCLUDE THE BELOW: H6: INVESTIGATION RESULTS UNDER TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSIONS. H11: INVESTIGATION SUMMARY: PROBLEM DESCRIPTION: ON 12/JUL/2024, CONVATEC HAINA ACKNOWLEDGED THE COMPLAINT RECORD IN DATABASE REPORTED FOR THE MALFUNCTION CODE ¿NO DEVICE MALFUNCTION DETERMINED BASED ON COMPLAINT INFORMATION PROVIDED (HARM REPORTED, OTHER USER/ CLINICAL REASONS FOR COMPLAINT)", IN WHICH THE CUSTOMER REPORTED THAT HE WAS HOSPITALIZED FOR UTI AND SEPSIS DUE TO THE URINE WILL NOT DRAIN DOWN INTO HIS NIGHTTIME DRAINAGE BAG. THE FAILURE MODE RELATED TO POUCH WILL NOT DRAIN WAS CAPTURED IN AN INITIAL COMPLAINT RECORD WITHIN DATABASE. THE LOT AFFECTED WAS 3K00260 - MATERIAL 1003666 ¿NATURA PCH URO ACU STD CLR 45MM (1X10)US¿. PHOTOGRAPH, VIDEO AND/OR PHYSICAL SAMPLE EVALUATION: NO PHOTOGRAPH ASSOCIATED WITH THIS CASE WAS RECEIVED, THE REPORTED DEFECT CANNOT BE SEEN. NO RETURN SAMPLE HAS BEEN RECEIVED FOR THIS COMPLAINT. PRODUCT & PROCESS DESCRIPTION: PRODUCT NAME: SUR-FIT 10" NATURA UROSTOMY BAG WITH 1-SIDED COMFORT PANEL, STANDARD, FAUCET WITH VALVE, CLEAR. INTENDED USE: THE SUR-FIT NATURA OSTOMY SYSTEM IS A COMPREHENSIVE PRODUCT LINE WITH OUR LATEST SKIN BARRIER TECHNOLOGIES. THE PLASTIC COUPLING RING ALLOWS THE POUCH AND SKIN BARRIER TO SNAP TOGETHER FOR AUDIBLE SECURITY. THESE UROSTOMY POUCHES HAVE AN EXTENDED ANTI-REFLUX VALVE, COMFORT PANELS, DRAINAGE TAP AND A UNIVERSAL NIGHT ADAPTOR. ACCORDING WITH RPT-010358 ¿CLINICAL EVALUATION REPORT DHF 59_CER¿, A CLINICAL EVALUATION WAS UNDERTAKEN FOR CONVATEC UROSTOMY AIDS, WHICH COMPRISE THE FOLLOWING DEVICES: NIGHT DRAINAGE CONTAINER SETS (DS10-018): NIGHT DRAINAGE CONTAINER SETS ARE NON-STERILE DEVICES DESIGNED FOR THE OVERNIGHT COLLECTION OF URINE. THEY HAVE A LARGER CAPACITY THAN LEG BAGS AND ARE CONNECTED TO UROSTOMY POUCHES OVERNIGHT, OR OVER AN EXTENDED PERIOD OF TIME. THE SETS INCLUDE A CONTAINER CONNECTED TO A TUBING CONNECTOR, DRAWSTRING BAG COVER TO PROVIDE PRIVACY AND A UNIVERSAL ADAPTOR. UNIVERSAL URINE COLLECTION BAGS ¿ S320/COMBIHESIVE (TP11-028): UNIVERSAL URINE COLLECTION BAGS, ALSO MARKETED AS SURGICARE NIGHT DRAINAGE SYSTEM, COMBIHESIVE COLLECTEUR D¿URINES DE NUIT (IN FRANCE), COMBIHESIVE SYSTEM AND SYSTEM 2 EUROPEAN NIGHT DRAINAGE BAG SYSTEM, IS A NON-STERILE DEVICE DESIGNED FOR THE OVERNIGHT COLLECTION OF URINE. THIS DEVICE IS MANUFACTURED BY A THIRD-PARTY MANUFACTURER, (B)(4), ON BEHALF OF CONVATEC LTD. THESE BAGS HAVE A LARGER CAPACITY THAN LEG BAGS AND ARE CONNECTED TO UROSTOMY POUCHES OVERNIGHT, OR OVER AN EXTENDED PERIOD OF TIME. THIS DRAINAGE SYSTEM INCLUDES A DRAINAGE CONTAINER CONNECTED TO TUBING. A HANGING ¿HANDLE¿ WAS SUPPLIED IN THE SECONDARY PACKAGING TO BE REPEATEDLY USED WITH SINGLE BAGS. NIGHT DRAINAGE ADAPTOR: THE NATURA UROSTOMY POUCH WITH ACCUSEAL TAP IS PROVIDED WITH A NIGHT DRAINAGE ADAPTOR. THIS ADAPTOR IS A ¿UNIVERSAL CONNECTOR¿ COMPRISES AN 185MM LENGTH OF PVC TUBING. IT ATTACHES TO THE ACCUSEAL TAP TO ALLOW CONNECTION TO A DRAINAGE SYSTEM, LEG OR BED BAG. THESE ARE USUALLY GRADUATED OR CHRISTMAS TREE TYPE ADAPTORS, TO BE CONNECTED. ACCORDING TO INFORMATION RECEIVED BY (B)(6) - EXECUTIVE CLINICAL SUPPORT NURSE, MENTIONED THAT THE CUSTOMER USES A BARD 4000ML BAG FOR NIGHT DRAINAGE AND A UROCARE #7632 1000ML LEG BAG. THIS INFORMATION WAS FORWARDED TO (B)(6) - MEDICAL AFFAIRS & CLINICAL DEVELOPMENT, FOR CLINICAL EVALUATION. SHE HAS REVIEWED THE BARD 4000ML BAG AND NOTED THAT ALTHOUGH THE WEBSITE DOES NOT PROVIDE DIMENSIONS OF THE CONNECTOR, IT APPEARS TO HAVE A GRADUATED TYPE OF CONNECTOR. THIS SUGGESTS THAT HIS NIGHT BAG MAY BE COMPATIBLE WITH OUR UNIVERSAL NIGHT DRAINAGE ADAPTOR. BATCH RECORD REVISION RESULTS: LOT 3K00260 WAS MANUFACTURED ON 02/OCT/2023, IN 2A LINE, WITH A TOTAL OF (B)(4) MARKET UNITS (MKUS). THE COMPLAINT INVESTIGATOR PERFORMED A BATCH RECORD REVIEW ON 19/AUG/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 1003666 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 NONCONFORMANCE REVIEW: ON 19/AUG/2024, COMPLAINTS INVESTIGATOR RAN A QUERY IN DATABASE LOOKING FOR ANY IN PROCESS NONCONFORMANCE / CORRECTIVE ACTION / PREVENTIVE ACTIONS (CAPA) ASSOCIATED TO THE DEFECT ¿TAP DOES NOT DRAIN¿ FOR HAINA SITE, FROM 01/AUG/2023 TO 19/AUG/2024, AS RESULT, NO NONCONFORMANCE / CORRECTIVE ACTION / PREVENTIVE ACTIONS (CAPA) RELATE TO THIS DEFECT WERE GENERATED DURING THE MANUFACTURING PROCESS. HISTORICAL COMPLAINTS REVIEW: ON 19/AUG/2024, COMPLAINTS INVESTIGATOR RAN A QUERY IN DATABASE IN ORDER TO VERIFY THE COMPLAINTS REPORTED FOR THE LOT 3K00260 FOR THE MALFUNCTION CODES ¿NO DEVICE MALFUNCTION DETERMINED BASED ON COMPLAINT INFORMATION PROVIDED (HARM REPORTED, OTHER USER/ CLINICAL REASONS FOR COMPLAINT)¿ AND ¿POUCH DOES NOT DRAIN (STOMAL CONTENTS WILL NOT PASS THROUGH), BLOCKAGE OR INADEQUATE DRAIN HOLE¿ AS RESULT, NO ADDITIONAL COMPLAINTS WERE IDENTIFIED. DATA REVIEW: DRAWINGS: THE DRAWINGS CORRESPONDING TO THE BAG AND TAP CONNECTORS WERE CHECKED IN ORDER TO UNDERSTAND THE DESIGN OF EACH COMPONENT. AS A RESULT, IT WAS POSSIBLE TO OBSERVE THAT THE TAP COMES IN THREE PARTS AND IS ASSEMBLED AT THE MANUFACTURING LINE (TAP BODY ACCUSEAL URO, TAP STEM ACCUSEAL UROSTOMY AND TAP CAP URO). 3AHH0005-F DRAWING (STEM ACCUSEAL TAP). 3AHH0006 - DRAWING (BODY ACCUSEAL TAP). 3ALD0007 (1) DRAWING (CAP FOR BOTTOM OUTLET TAP). 3ALL0020-B DRAWING (UROSTOMY STANDARD - SIZES THRU 70). RPT-010358 ¿CLINICAL EVALUATION REPORT - CONVATEC UROSTOMY AIDS DHF 59_CER¿. VER 1.0: AN ARCHIVAL VERIFICATION OF THE CLINICAL EVALUATION OF CONVATEC UROSTOMY AIDS HAS BEEN PERFORMED TO MEET THE RELEVANT GENERAL SAFETY AND PERFORMANCE REQUIREMENTS (GSPR). THE MAIN AIM OF THIS CLINICAL EVALUATION WAS TO DETERMINE WHETHER SUFFICIENT CLINICAL DATA EXISTS TO CONTINUE TO DEMONSTRATE THE NECESSARY SAFETY AND PERFORMANCE CRITERIA FOR UROSTOMY AIDS. AS RESULTS WAS VERIFIED THAT UROSTOMY AIDS HAS GROUPED TOGETHER THE FOLLOWING DEVICES BY TECHNOLOGY: NIGHT DRAINAGE CONTAINER SETS. UNIVERSAL URINE COLLECTION BAG S320/COMBIHESIVE. UROSTOMY CONNECTORS. THERE ARE CLASS I MEDICAL DEVICES, AND IN THE UNITED STATES ARE CLASS I EXEMPT DEVICES. THESE ARE NON-INVASIVE AND REUSABLE. UNIVERSAL URINE COLLECTION BAGS AND UROSTOMY CONNECTORS ARE SINGLE PATIENT USE DEVICES, AND NIGHT DRAINAGE CONTAINER SETS ARE SINGLE PATIENT RE-USE DEVICES. UROSTOMY AIDS ARE DESIGNED FOR THE OVERNIGHT COLLECTION OF URINE. UNIVERSAL URINE COLLECTION BAGS HAVE A LARGER CAPACITY THAN LEG BAGS AND ARE CONNECTED TO UROSTOMY POUCHES OVERNIGHT OR OVER AN EXTENDED PERIOD. FOR BOTH THE NIGHT DRAINAGE CONTAINER SETS AND THE UNIVERSAL URINE COLLECTION BAGS THAT SERVE AS ACCESSORIES OR CONNECTORS THAT FACILITATE THE CONNECTION OF UROSTOMY SYSTEMS WITH THESE URINE COLLECTION SYSTEMS. VAM 403F UROSTOMY NIGHT DRAINAGE BOTTLE SUR FIT SYSTEM GF: THE GUIDE FORMULA FOR THE UROSTOMY NIGHT DRAINAGE BOTTLE WAS VERIFIED IN ORDER TO UNDERSTAND THE FORMULA, USE AND COMPONENTS OF THE BOTTLE. AS A RESULT, IT WAS VERIFIED THAT THIS SET CONSISTS OF A PLASTIC GRADUATED CONTAINER (2,000 CC CAPACITY), TUBING WITH ATTACHED ACCUSEAL CONNECTORS AND A CLOTH COVER. THE CONTAINER SET IS DESIGNED FOR USE WITH THE SUR-FIT UROSTOMY POUCH WITH ACCUSEAL TAP. ALSO INCLUDED IS A UNIVERSAL ADAPTER FOR ATTACHING THE TUBBING TO A REGULAR SUR-FIT. THIS SET IS USED FOR THE NIGHT-TIME COLLECTION OF URINE. THE COMPONENTS OF THE NIGHT DRAINAGE CONTAINER SET ARE: (ACCUSEAL CONNECTORS AND ACCESSORIES, PVC INLET TUBING, FLIP -ON CAP, NIGHT DRAINAGE BOTTLE, DRAW-STRING VANITY BAG AND UNIVERSAL ADAPTER). RSK-008500 ¿HAZARD ANALYSIS REPORT - DHF 91_HAR¿. THE PURPOSE OF THIS HAZARD ANALYSIS REVIEW IS TO IDENTIFY, ANALYZE AND EVALUATE THE INDIVIDUAL RISKS ASSOCIATED WITH THE ABOVE REFERENCED PRODUCTS. OSTOMY COLLECTION SYSTEMS ARE INTENDED FOR THE COLLECTION OF STOMAL OUTPUT AND ARE TYPICALLY COMPRISED OF TWO ELEMENTS: A SKIN BARRIER WAFER AND A POUCH. THE SKIN BARRIER WAFER AND THE POUCH MAY BE ASSEMBLED INTO ONE DEVICE (ONE-PIECE SYSTEMS) OR SUPPLIED SEPARATELY AS TWO DEVICES (TWO-PIECE SYSTEMS). TWO-PIECE SYSTEMS DIFFER FROM ONE-PIECE SYSTEMS IN THAT THE POUCH IS NOT DIRECTLY ADHERED TO THE WEARER¿S SKIN. INSTEAD, A COUPLING MECHANISM IS USED TO CONNECT THE POUCH TO THE ADHESIVE SKIN BARRIER WAFER THAT IS ADHERED TO THE WEARER¿S SKIN AT THE STOMA. SUMMARY OF INVESTIGATION: BASED ON THE CAUSES STATED BY THE CUSTOMER, HE ESTABLISHES THAT THE BACKFLOW PREVENTER IS BLOCKING THE ACCUSED TAP BECAUSE THE URINE WILL NOT DRAIN DOWN INTO HIS NIGHTTIME DRAINAGE BAG. ANALYZING THIS CAUSE EXPOSED BY THE CUSTOMER THE ANTI-REFLUX OR (SPOTS/ANTI-REFLUX VALVE) ARE WELDING POINTS ON THE FILM THAT LIMIT THE DISPLACEMENT OF THE POUCH CONTENTS TO THE OUTSIDE OF THE POUCH. THEY DO NOT INTERACT WITH THE DRAINAGE PART (TAP) AND THEREFORE DO NOT AFFECT URINE DRAINAGE. THE CUSTOMER STATES THAT HE CONNECTS TO A NIGHT DRAINAGE BAG AT NIGHT AND A LEG BAG DURING THE DAY. HE ALSO REPORTS THAT REFLUX PROBLEMS ONLY OCCUR AT NIGHT. ANALYZING THIS STATEMENT, IF THE TAP DRAINS CORRECTLY WITH THE LEG BAG, IT SHOULD WORK THE SAME AS THE NIGHT BAG COLLECTED. BASED ON THIS ANALYSIS, IT COULD BE DEDUCED THAT THE PROBLEM COULD BE GENERATED IN THE NIGHT BAG RATHER THAN IN THE UROSTOMY POUCH. IT WAS ALSO EVALUATED A FEW DIFFERENT POSSIBLE CAUSES RELATE TO THE URINE WILL NOT DRAIN DOWN INTO HIS NIGHTTIME DRAINAGE BAG IDENTIFIED BY THE MULTIFUNCTIONAL TEAM: 1. CLOSED TAP VALVE: IF THE CUSTOMER HAS THE TAP VALVE CLOSED COULD PREVENTS THE PASSAGE OF URINE, RESULTING IN FILLING OF THE POUCH AND, POTENTIALLY, LEAKAGE OF URINE THROUGH THE REFLUX. HOWEVER, IN THE CUSTOMER REPORT IT STATES THAT HE BACKFLOW PREVENTER ONLY FAILS DURING NIGHT BAG, BECAUSE HE ALSO USES A LEG BAG DURING THE DAY WHICH DRAINS CORRECTLY. THIS MEANS THAT THE CLIENT HAD THE TAP VALVE OPEN. THIS CAUSE HAS BEEN RULED OUT. 2. OBSTRUCTION IN THE TAP VALVE: THE OBSTRUCTED TAP CAN BLOCK THE FLOW OF URINE, LEADING TO A BUILDUP INSIDE THE POUCH AND CAUSING SLIGHT LEAKAGE. THE TAP MAY BECOME BLOCKED BY A THICK SUBSTANCE, OR ITS PARTS MAY BE OUT OF SPECIFICATION, LEADING TO CLOGGING. THE TAP COMES IN THREE PARTS AND IS ASSEMBLED AT THE MANUFACTURING LINE (TAP BODY ACCUSEAL URO, TAP STEM ACCUSEAL UROSTOMY AND TAP CAP URO). ON 17/JUL/2024, SUPPLIER QUALITY ENGINEER RAN A QUERY IN DATABASE IN ORDER TO VERIFY THE SUPPLIER CORRECTIVE ACTION REPORT (SCAR) REPORTED FOR THE LOTS (40900005, 40900004, 1090834616) ASSOCIATED TO THE DEFECT ¿OUT OF SPECIFICATION¿ AS RESULT, NO SUPPLIER CORRECTIVE ACTION REPORT (SCAR) WERE FOUND INDICATING THAT ANY OF THE REPORTED BATCHES WERE USED IN THE PRODUCTION OF THE DEFECTIVE BATCH. THIS CAUSE HAS BEEN RULED OUT. 3. AIR VOIDS (BUBBLES) IN THE NIGHT BAG AND CONNECTING TUBE: AIR VOIDS CAN CREATE BACKFLOW PRESSURES. COMPLAINT HANDLE TEAM ADVISED THE CUSTOMER TO MAKE SURE HE HAS A COUPLE INCHES OF URINE IN HIS POUCH, ENOUGH TO FLUSH THE TUBING BECAUSE THIS CAN HELP PREVENT URINE FROM NOT DRAINAGE DOWN INTO HIS NIGHT TIME DRAINAGE BAG, THE CUSTOMER STATE THAT THIS ISSUE CAN HAPPEN WITH OR WITHOUT KEEPING SOME URINE IN HIS POUCH. THIS CAUSE HAS BEEN RULED OUT. CONCLUSIONS: NO PHOTOGRAPHS FOR THIS COMPLAINT ISSUE. THEREFORE, IT WAS NOT POSSIBLE TO CONFIRM THE COMPLAINT. THE POSSIBLE CAUSE EXPOSED BY THE CUSTOMER ¿BACKFLOW PREVENTER IS BLOCKING THE ACCUSED TAP BECAUSE THE URINE WILL NOT DRAIN DOWN INTO HIS NIGHTTIME DRAINAGE BAG¿ WAS RULED OUT BECAUSE THE ANTI-REFLUX IS WELDING POINTS ON THE FILM THAT LIMIT THE DISPLACEMENT OF THE POUCH CONTENTS TO THE OUTSIDE OF THE POUCH. THEY DO NOT INTERACT WITH THE DRAINAGE PART (TAP) AND THEREFORE DO NOT AFFECT URINE DRAINAGE. IN ADDITION, THE CUSTOMER STATES THAT HE CONNECTS TO A NIGHT DRAINAGE BAG AT NIGHT AND A LEG BAG DURING THE DAY. HE ALSO REPORTS THAT REFLUX PROBLEMS ONLY OCCUR AT NIGHT. DURING THE INVESTIGATION IT WAS IDENTIFIED THAT IF THE TAP DRAINS CORRECTLY WITH THE LEG BAG, IT SHOULD WORK THE SAME AS THE NIGHT BAG COLLECTED. BASED ON THIS ANALYSIS, IT COULD BE DEDUCED THAT THE PROBLEM COULD BE GENERATED IN THE NIGHT BAG RATHER THAN IN THE UROSTOMY POUCH. ALSO, THE POSSIBLE CAUSES IDENTIFIED BY THE MULTIFUNCTIONAL TEAM HAVE BEEN RULED OUT. A REVIEW OF BATCH RECORDS 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 DISCREPANCIES RELATED TO THIS ISSUE WERE FOUND WITHIN THE DOCUMENTATION. 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.
THE END USER REPORTED THAT HE BELIEVED THERE WAS A DESIGN FLAW IN THE PRODUCT THAT NEEDED TO BE CORRECTED. IT WAS STATED THAT THE URINE BACKED UP INTO THE STOMA. THE END USER MENTIONED THAT HE WAS RECENTLY HOSPITALIZED WITH A URINARY TRACT INFECTION (UTI) AND SEPSIS, WHICH REQUIRED TREATMENT WITH CIPROFLOXACIN ANTIBIOTICS. NO PHOTO WAS AVAILABLE AT THIS TIME.
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1046128 | NATURA | BAG, URINARY, ILEOSTOMY | EXH | CONVATEC DOMINICAN REPUBLIC INC | 401544 | 3K00260 | 00768455182787 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 82 YR | Male |