ACTIVELIFE
Report
- Report Number
- 9618003-2026-00903
- Event Type
- Malfunction
- Date Received
- May 8, 2026
- Report Date
- April 15, 2026
- Manufacturer
- CONVATEC DOMINICAN REPUBLIC INC
- Product Code
- FON
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CT, US
- Reporter Occupation
- OTHER
Narratives
MDR ./ DEVICE 15 OF 21. BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A REPORTABLE MALFUNCTION. REQUEST WAS PERFORMED FOR ADDITIONAL INFORMATION INCLUDING LOT NUMBER; HOWEVER, LOT NUMBER WAS NOT PROVIDED. A COMPLAINT INVESTIGATION WAS INITIATED. UNFORTUNATELY, NO SPECIFIC LOT NUMBER WAS IDENTIFIED, WHICH LIMITS THE ABILITY TO TRACE OR ANALYZE A PARTICULAR ITEM. CURRENT QUALITY CONTROLS DURING THE MANUFACTURING PROCESS: SINCE THE COMPLAINT DID NOT INCLUDE A SPECIFIC LOT NUMBER, THE INVESTIGATION USED THE PART NUMBER AND PRODUCT DESCRIPTION PROVIDED TO IDENTIFY THE CORRESPONDING MANUFACTURING LINE, THE RELEVANT PRODUCT: ACTIVE LIFE PCH SM TAN 25MM (1X10PK) US. BASED ON THIS INFORMATION, PROCESS INSTRUCTION PROCESS INSTRUCTION (PI), CORRESPONDING TO THE GUARD, WAS IDENTIFIED. THE ASSOCIATED IN PROCESS CONTROLS WERE REVIEWED TO CONFIRM THAT THE CONTROLS ESTABLISHED FOR THIS MANUFACTURING LINE ARE ADEQUATE TO DETECT AND PREVENT THE REPORTED FAILURE MODE. DIMENSIONAL: WIDTH OF SRP PEEL TAB FREQUENCY: EVERY 30 MINUTES SAMPLE QUANTITY: ONE (1) UNIT PER HEAD ACCEPTANCE CRITERIA: ACCEPT = 0 REJECT = 1 DIMENSIONAL: WIDTH OF THE OUTLINE WELD FREQUENCY: EVERY 30 MINUTES SAMPLE QUANTITY: ONE (1) UNIT PER HEAD ACCEPTANCE CRITERIA: ACCEPT = 0 REJECT = 1 DIMENSIONAL: BELT TAB ROTATION FREQUENCY: EVERY 30 MINUTES SAMPLE QUANTITY: ONE (1) UNIT PER HEAD ACCEPTANCE CRITERIA: ACCEPT = 0 REJECT = 1 VISUAL: CONCENTRICITY OF THE PROTECTIVE SHIELD FREQUENCY: EVERY 30 MINUTES SAMPLE QUANTITY: ONE (1) UNIT PER HEAD ACCEPTANCE CRITERIA: ACCEPT = 0 REJECT = 1 DIMENSIONAL AS PER DRAWING FREQUENCY: TWICE PER SHIFT (ABOUT EVERY 4 HOURS) SAMPLE QUANTITY: ONE (1) UNIT PER HEAD ACCEPTANCE CRITERIA: ACCEPT = 0 REJECT = 1 TEST METHODS (TM) "VISUAL INSPECTION" FREQUENCY: CONTINUOUS INSPECTION SAMPLE QUANTITY: CONTINUOUS VISUAL INSPECTION ACCEPTANCE CRITERIA: ACCEPT = 0 REJECT = 1 RISK MANAGEMENT: ALL INSPECTIONS AND CONTROLS WERE DOCUMENTED IN DHF346 HAR RSK 024671 ANALYSED FOR THE DEVICE SPECIFICATION. THE SEVERITY OF POTENTIAL FAILURE MODES IS RATED AS 4 (SERIOUS), AND THE OCCURRENCE IS 1 (REMOTE). ACCORDING TO RISK MANAGEMENT PROCEDURE STANDARD OPERATING PROCEDURE (SOP), THE LIKELIHOOD OF HARM TO THE END USER IS CONSIDERED HIGHLY UNLIKELY DUE TO THE EFFECTIVENESS OF THE CONTROLS IN PLACE. FINDINGS: BASED ON AN IN-DEPTH REVIEW OF THE MANUFACTURING AND IN PROCESS INSPECTION CONTROLS FOR THE PRODUCT REFERENCED ABOVE, IT WAS DETERMINED THAT COMPREHENSIVE AND ROBUST QUALITY CONTROLS WERE IMPLEMENTED TO MONITOR CRITICAL DIMENSIONAL AND VISUAL CHARACTERISTICS THROUGHOUT THE MANUFACTURING PROCESS. THESE CONTROLS INCLUDED HIGH FREQUENCY DIMENSIONAL INSPECTIONS PERFORMED EVERY 30 MINUTES PER PRODUCTION HEAD FOR KEY PRODUCT ATTRIBUTES, SUCH AS SRP PEEL TAB WIDTH, OUTLINE WELD WIDTH, AND BELT TAB ROTATION, AS WELL AS ROUTINE VISUAL VERIFICATION OF PROTECTIVE SHIELD CONCENTRICITY. IN ADDITION, DIMENSIONAL CONFORMITY TO APPROVED DRAWINGS WAS VERIFIED TWICE PER SHIFT, AND CONTINUOUS VISUAL INSPECTION WAS CONDUCTED IN ACCORDANCE WITH TM "VISUAL INSPECTION". ALTHOUGH NO LOT NUMBER WAS AVAILABLE TO ALLOW FOR FULL TRACEABILITY IN THIS COMPLAINT, THE ESTABLISHED INSPECTION FREQUENCIES, DEFINED ACCEPTANCE CRITERIA, AND CONTINUOUS VISUAL OVERSIGHT PROVIDED A STRONG LEVEL OF ASSURANCE THAT POTENTIAL NONCONFORMITIES WOULD BE DETECTED AND ADDRESSED DURING MANUFACTURING. THE CONTROLS REVIEWED ARE FORMALLY DOCUMENTED, ROUTINELY EXECUTED, AND VERIFIED AS PART OF STANDARD MANUFACTURING OPERATIONS. TREND ANALYSIS: AS PART OF THE INVESTIGATION, A REVIEW WAS CONDUCTED OF COMPLAINTS CATEGORIZED UNDER "SKIN BARRIER STARTER HOLE IS DEFECTIVE (E.G. MISALIGNMENT OR OFF CENTER), LEAKAGE MAY OCCUR (PRE-CUT ONLY)" ASSOCIATED WITH PRODUCTS MANUFACTURED ON THE SAME PRODUCTION LINE. THE ANALYSIS COVERED DATA FROM 2024 TO 2026, AND NO ADDITIONAL RELATED COMPLAINTS WERE IDENTIFIED. THE REVIEW INDICATES THAT THERE IS NO TREND OR RECURRING PATTERN ASSOCIATED WITH THIS FAILURE MODE ON THE REFERENCED PRODUCTION LINE. BASED ON THE INFORMATION AVAILABLE FOR THIS COMPLAINT, THERE IS NO EVIDENCE TO CONFIRM A DEVICE MALFUNCTION RELATED TO THE REPORTED CONDITION. DUE TO LIMITED INFORMATION AND THE ABSENCE OF PRODUCT RETURN OR ADDITIONAL SUPPORTING DATA, A DEFINITIVE CAUSAL RELATIONSHIP TO THE POUCH COULD NOT BE ESTABLISHED, AND IT IS NOT POSSIBLE TO FULLY DETERMINE THE SEQUENCE OF EVENTS THAT LED TO THE REPORTED OUTCOME. PERSONNEL NOTIFICATION: AS PART OF THE INVESTIGATION, THE TEAMS INVOLVED IN THE MANUFACTURING OF THE AFFECTED PRODUCT WERE INFORMED ABOUT THE REPORTED ISSUE. THE GOAL WAS TO RAISE AWARENESS AND REINFORCE THE IMPORTANCE OF INSPECTION PROTOCOLS. NOTIFICATIONS WERE CARRIED OUT ACROSS ALL SHIFTS AND SERVED AS A REMINDER TO REMAIN VIGILANT AND MAINTAIN HIGH STANDARDS IN DAILY OPERATIONS. THIS EFFORT HELPED ENSURE THAT EVERYONE INVOLVED CONTINUES TO FOLLOW ESTABLISHED CONTROLS AND REMAINS ATTENTIVE TO ANY SIGNS OF DEVIATION. ATTACHMENTS: 29APR2026 PERSONAL NOTIFICATION CONCLUSION: ALTHOUGH A SPECIFIC LOT NUMBER WAS NOT PROVIDED, WHICH LIMITED THE ABILITY TO PERFORM A TARGETED REVIEW OF MANUFACTURING RECORDS, THE COMPLAINT WAS INVESTIGATED USING THE AVAILABLE PART NUMBER, PRODUCT DESCRIPTION, AND THE CORRESPONDING MANUFACTURING PROCESS. THE APPLICABLE PRODUCTION LINE AND RELATED PROCESS INSTRUCTIONS WERE REVIEWED, AND THE IN PROCESS DIMENSIONAL AND VISUAL CONTROLS WERE CONFIRMED TO BE OPERATING AS INTENDED. NO MANUFACTURING DEVIATIONS, MATERIAL CONCERNS, OR PROCESS ISSUES WERE IDENTIFIED THAT COULD REASONABLY BE LINKED TO THE REPORTED CONDITION. A REVIEW OF HISTORICAL COMPLAINTS ASSOCIATED WITH FAILURE MODE FOR PRODUCTS MANUFACTURED ON THE SAME LINE BETWEEN 2024 AND 2026 DID NOT IDENTIFY ADDITIONAL RELATED COMPLAINTS OR EVIDENCE OF A RECURRING ISSUE. IN THE ABSENCE OF A PRODUCT RETURN OR ADDITIONAL SUPPORTING INFORMATION, A DEFINITIVE CAUSAL RELATIONSHIP TO THE DEVICE COULD NOT BE ESTABLISHED. BASED ON THE INFORMATION AVAILABLE, THERE IS NO EVIDENCE TO CONFIRM A MANUFACTURING RELATED DEVICE MALFUNCTION. OVERALL, THE INVESTIGATION SUPPORTS THAT THIS COMPLAINT REPRESENTS AN ISOLATED EVENT WITH NO INDICATION OF A SYSTEMIC ISSUE. 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 CONSUMER REPORTED THAT THE PRECUT OPENING WAS OFF-CENTERED. SHE ESTIMATED THAT APPROXIMATELY TEN¿TWENTY POUCHES WERE AFFECTED, ALTHOUGH THE TOTAL NUMBER OF MARKET UNITS WAS UNKNOWN. THE ISSUES HAD BEEN ONGOING AND HAD WORSENED OVER THE PAST THREE MONTHS. ADDITIONALLY, SHE STATED THAT PROBLEMS WITH THE STARTER HOLE HAD BEEN PRESENT FOR LONGER THAN THREE MONTHS, NOTING THAT OVER THE PAST YEAR SHE HAD EXPERIENCED APPROXIMATELY TWO BOXES IN WHICH EVERY POUCH HAD AN OFF-CENTERED STARTER HOLE. SHE ALSO REPORTED THAT SHE WOULD USUALLY DISCARD THOSE DEFECTIVE POUCHES. NO PHOTO IS AVAILABLE AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 280318 | ACTIVELIFE | BAG, DRAINAGE, WITH ADHESIVE, OSTOMY | FON | CONVATEC DOMINICAN REPUBLIC INC | 022751 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR | Female |