AQUACEL FOAM
Report
- Report Number
- 1000317571-2026-00020
- Event Type
- Malfunction
- Date Received
- February 18, 2026
- Date of Event
- January 21, 2026
- Report Date
- January 21, 2026
- Manufacturer
- CONVATEC LTD
- Product Code
- NAC
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- 003
Narratives
D1: CORRECT BRAND NAME IS CONVAFOAM NON-ADHESIVE WHICH IS UNAVAILABLE FOR SELECTION IN DATABASE. HENCE, PLEASE DISREGARD AQUACEL FOAM AND CONSIDER CONVAFOAM NON-ADHESIVE. E1: COMPLAINANT CITY: DEESIDE. COMPLAINANT COUNTRY: UNITED KINGDOM. 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: 1000317571.
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. COMPLAINT CODE: FOREIGN MATTER WITHIN PRODUCT, STERILE PRODUCTS (E.G. METAL CONTAMINATION IN DRESSINGS, PARTICULATES WITHIN FLUIDS, GELS ETC), REGION: UNITED KINGDOM, PRODUCT / SYSTEM APPLICATION PRODUCT (SAP): 1733756 CONVAFOAM NADH 20X20CM (1X5PK) EUR, LOT: 5F00332, DATE OF MANUFACTURE: 05 JUN 2025, STERILISATION: (B)(4) 12 JUNE 2025, BATCH SIZE: (B)(4) SECONDARY UNITS ((B)(4) PRIMARY). A COMPLAINT WAS RECEIVED FROM UK CONVATEC GDC REPORTING CONTAMINATION ON THE HYDROFIBER LAYER OF THE CONVAFOAM DRESSING. APPROXIMATELY 1 CENTIMETRE (CM) IN SIZE AT THE CORNER OF THE DRESSING. FOR MATERIAL: 1733756 BATCH 5F00332. THE LOT WAS MANUFACTURED ON 05 JUN 2025 AND STERILISED UNDER (B)(4) 12 JUNE 2025. (B)(4) PRIMARY UNITS IMPACTED FROM (B)(4) SECONDARY UNITS ((B)(4) PRIMARY). THREE PHOTOGRAPHS WAS PROVIDED BY THE COMPLAINANT TO DEMONSTRATE THE REPORTED MARKS/CONTAMINATION ON ONE OF THE DRESSINGS. THE IMAGE SHOWS MULTIPLE IRREGULAR DARK BROWN/BLACK FOREIGN PARTICULATES, INCLUDING FRAGMENTED DEBRIS AND FINE FIBROUS STRANDS, WERE OBSERVED CLUSTERED ON THE SURFACE OF THE CONVAFOAM DRESSING, WITH CONTAMINATION CLEARLY VISIBLE ON THE UNIT. NO PHYSICAL SAMPLES WERE RETURNED TO CONVATEC FOR EVALUATION. THE ABSENCE OF RETURNED PRODUCT LIMITS THE ABILITY TO PERFORM A DETAILED, HANDS-ON ASSESSMENT OF THE DEFECT. WITHOUT HIGHER-RESOLUTION IMAGES OR PHYSICAL SAMPLES, THE DEPTH OF INVESTIGATION IS RESTRICTED, AND A DEFINITIVE ROOT CAUSE CANNOT BE FULLY ESTABLISHED. THE ASSESSMENT IS THEREFORE BASED SOLELY ON THE LIMITED PHOTOGRAPHIC EVIDENCE AVAILABLE. A FULL BATCH RECORD REVIEW WAS COMPLETED FOR LOT 5F00332. ALL QUALITY CONTROL (QC) INSPECTIONS AND FINAL RELEASE ACTIVITIES WERE RECORDED AS ACCEPTABLE. NO MATERIAL-RELATED OR CONTAMINATION-RELATED ISSUES WERE DOCUMENTED. GOOD MANUFACTURING PRACTICES (GMP) COMPLIANCE RECORDS CONFIRM APPROPRIATE GOWNING, ENVIRONMENTAL MONITORING, AND ADHERENCE TO DEFINED PROCEDURES DURING THE PRODUCTION PERIOD. NO CORRECTIVE ACTION / PREVENTIVE ACTIONS (CAPA) (S) OR NONCONFORMANCES WERE RAISED IN RELATION TO THE PRODUCTION FOR ORDER (B)(4). NO PROCESS DEVIATIONS OR CONTAMINATION-RELATED NONCONFORMANCES WERE IDENTIFIED FOR LOT 5F00332. NO ADDITIONAL COMPLAINTS HAS BEEN ASSIGNED TO BATCH 5F00332¿ 12 MONTH LOOKBACK. A BROADER MATERIAL-LEVEL REVIEW FOR MATERIAL 1733756 (CONVAFOAM NADH 20X20CM (1X5PK) EUR) IDENTIFIED NO FURTHER COMPLAINTS. NO FURTHER COMPLAINTS RAISED ALL CONVAFOAM DERIVATIVES 12 MONTH LOOK BACK. THE CURRENT COMPLAINT RELATES TO ONE PRIMARY PACK REPORTED WITH CONTAMINATION. THE TOTAL BATCH SIZE WAS (B)(4) SECONDARY UNITS (EQUIVALENT TO (B)(4) PRIMARY UNITS). OF THESE, ALL (B)(4) SECONDARY UNITS ARE DISTRIBUTED TO UK DISTRIBUTION CENTRES (DC), WITH NO ADDITIONAL FEEDBACK OF SIMILAR ISSUES, AND ALL (B)(4) UNITS REMAIN IN DC INVENTORY WITHOUT REPORTED DEFECTS. GIVEN THE LOW OCCURRENCE RATE ((B)(4) REPORTED EVENT (IMPACTING (B)(4) PRIMARY PACKS) OUT OF (B)(4) SECONDARY UNITS - (B)(4) PRIMARY UNITS), THE COMPLAINT FREQUENCY REMAINS LOW RELATIVE TO THE TOTAL DISTRIBUTED QUANTITY. THE AVAILABLE EVIDENCE DOES NOT SUGGEST A SYSTEMIC OR BATCH-WIDE MANUFACTURING ISSUE. ALTHOUGH NO OTHER COMPLAINT WITH THE SAME MALFUNCTION CODE HAS BEEN RAISED FOR THIS BATCH, THERE WAS NO EVIDENCE OF CORRELATED DEVIATIONS, COMMON DEFECT SIGNATURES, OR RECURRING CONTAMINATION MECHANISMS. NO ADDITIONAL SIMILAR COMPLAINTS HAVE BEEN IDENTIFIED ACROSS DISTRIBUTED UNITS OF BATCH 5F00332. BASED ON THE COMBINED DATA SET, THE RISK TO PRODUCT QUALITY AND PATIENT SAFETY REMAINS MINIMAL, AND THE EVENTS APPEAR LIMITED IN SCOPE WITH NO INDICATION OF A SYSTEMIC FAILURE MODE. ACROSS THE FULL MANUFACTURED POPULATION OF (B)(4) SECONDARY PACKS ((B)(4) PRIMARY UNITS): ONLY ONE CONTAMINATION-RELATED COMPLAINT HAS BEEN RECEIVED. BATCH RECORD REVIEW, IN-PROCESS INSPECTIONS, AND DEVICE HISTORY CHECKS IDENTIFIED NO DEVIATIONS, NO RECURRING ISSUES, AND NO PROCESS-RELATED TRENDS. THE OBSERVED DEFECT RATE ((B)(4) PRIMARY UNITS OUT OF (B)(4) PRIMARY PACKS = (B)(4)) REMAINS BELOW THE NOTIONAL (B)(4) ACCEPTABLE QUALITY LEVEL (AQL) LIMIT, CONFIRMING NO EVIDENCE OF AN AQL EXCURSION. BASED ON WORK INSTRUCTION (WI) RISK ASSESSMENT CRITERIA, THE EVENT DOES NOT REPRESENT INCREASED RISK TO PATIENT SAFETY, DEVICE PERFORMANCE, OR REGULATORY COMPLIANCE. IN ALIGNMENT WITH WORK INSTRUCTION (WI), THERE IS NO EVIDENCE OF A SYSTEMIC FAILURE MODE, RECURRING DEFECT SIGNATURE, OR RISK ESCALATION THAT WOULD NECESSITATE CAPA. THEREFORE, CAPA WAS NOT REQUIRED, AND THE COMPLAINT WILL CONTINUE TO BE MONITORED THROUGH ROUTINE POST-MARKET PRODUCT MONITORING AND TREND REVIEW PROCESSES. THREE PHOTOGRAPHS WERE PROVIDED AND NO PHYSICAL SAMPLE WAS RETURNED, THE CONTAMINATION MECHANISM CANNOT BE CONCLUSIVELY DETERMINED. THE DARK SPOT OBSERVED IN THE IMAGE IS CONSISTENT WITH SEVERAL PLAUSIBLE SOURCES OF CONTAMINATION, INCLUDING: CONVERTING / SLITTING / REELSTOCK HANDLING. BUILD-UP OF CARBONISED ADHESIVE, DUST, OR DEGRADED POLYMER ON ROLLERS OR GUIDES. FIBRE SHEDDING FROM CORE PLUGS, CARDBOARD EDGES, OR PACKAGING MATERIALS. ENTRAPMENT DURING MANUAL REEL CHANGEOVER. STATIC ATTRACTION PULLING AIRBORNE DEBRIS ONTO EXPOSED ADHESIVE. PACKAGING LINE: CARTON DUST OR FIBRE FRAGMENTS DROPPING INTO OPEN DRESSINGS. DEBRIS FROM WORN BELTS OR GUIDES. ENVIRONMENTAL FALLOUT DURING STOPPAGES OR LINE CLEARANCE GAPS. POST-PROCESS HANDLING (BEFORE PRIMARY SEAL): IF THE DRESSING WAS EXPOSED PRIOR TO POUCH SEALING: OPERATORS CONTACT CONTAMINATION. BENCH OR STAGING AREA CONTAMINATION. TRANSFER TRAYS NOT ADEQUATELY CLEANED. GIVEN IT¿S CLUSTERED (NOT EVENLY SPREAD), IT MOST STRONGLY SUGGESTS POINT-SOURCE SHEDDING (A DIRTY CONTACT POINT/TOOLING OR AN INTERVENTION) RATHER THAN GENERAL AIRBORNE FALLOUT. DUE TO THE LIMITED EVIDENCE AVAILABLE, NO SINGLE ROOT CAUSE CAN BE CONFIRMED. THE DRESSINGS ARE INSPECTED BY OPERATORS, BUT AS THE FOREIGN MATTER IS OF SUCH A SMALL SIZE (APPROXIMATELY 1CM ON THE TAPPI CHART INDICATED), THIS FOREIGN MATTER MAY NOT HAVE BEEN READILY DETECTABLE AT VALIDATED INSPECTION SPEEDS. GIVEN THE ABSENCE OF REPEAT EVENTS, ABSENCE OF ANY CORRELATED DEVIATIONS, AND NO SIMILAR COMPLAINTS ACROSS THE DISTRIBUTED UNITS, THE RISK TO PRODUCT QUALITY AND PATIENT SAFETY IS ASSESSED AS MINIMAL. THE EVENT APPEARS TO BE ISOLATED, WITH NO EVIDENCE OF A SYSTEMIC FAILURE MODE. DETECTION OF SURFACE CONTAMINATION CURRENTLY RELIES ON VALIDATED MANUAL VISUAL INSPECTION. THE LINE WAS SCHEDULED FOR FUTURE ENHANCEMENT WITH VISION CAPABILITY, WHICH WILL FURTHER STRENGTHEN DEFECT DETECTION ROBUSTNESS. IN SUMMARY, THE CONTAMINATION OCCURRED AS A RESULT OF TRANSFER FROM CONTAMINATED TOOL WARE OR FROM OPERATOR ORIGIN COMBINED WITH HUMAN ERROR IN DEFECT DETECTION. CONTRIBUTING FACTORS INCLUDE HIGH LINE SPEED, LIMITED INSPECTION VISIBILITY, AND THE ABSENCE OF AN AUTOMATED VISION SYSTEM. THE OPTIMA LINE IS SCHEDULED FOR RENOVATION, INCLUDING THE IMPLEMENTATION OF A VISION SYSTEM. THIS PLANNED UPGRADE WILL ADDRESS THE CORE DETECTION LIMITATIONS THAT CONTRIBUTED TO THIS EVENT. AS ONLY ONE UNIT WAS AFFECTED, THE BATCH REMAINS WITHIN SPECIFICATION AND ACCEPTABLE QUALITY LIMITS. THE ISSUE IS CONSIDERED ISOLATED, WITH NO EVIDENCE OF SYSTEMIC RECURRENCE. NO CAPA IS REQUIRED. THE COMPLAINT WILL BE MONITORED THROUGH ROUTINE TRENDING AND THE POST MARKET PRODUCT MONITORING REVIEW PROCESS (STANDARD OPERATING PROCEDURE (SOP)). 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: 1000317571.
A CONTAMINATION WAS OBSERVED DURING TESTING ON HYDROFIBER LAYER OF THE DRESSING. THE AFFECTED AREA MEASURED APPROXIMATELY ONE CM AND WAS LOCATED AT THE CORNER OF THE DRESSING. THE ISSUE WAS IDENTIFIED UPON INSPECTION OF THE PRODUCT, AS SHOWN IN THE ATTACHED IMAGES.
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 219661 | AQUACEL FOAM | DRESSING, WOUND, HYDROPHILIC | NAC | CONVATEC LTD | 423360 | 5F00332 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |