AQUACEL EXTRA

Report

Report Number: 1000317571-2026-00050
Event Type: Malfunction
Date Received: March 30, 2026
Report Date: March 6, 2026
Manufacturer: CONVATEC LTD
Product Code: NAC
UDI-DI: 00768455125630
PMA / PMN Number: EXEMPT
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: 003

Narratives

Additional Manufacturer Narrative · 0

DEVICE 1 OF 3. E1: COMPLAINANT STREET ADDRESS: (B)(6). COMPLAINANT CITY: (B)(6). COMPLAINANT POSTAL CODE: (B)(6). COMPLAINANT PHONE: (B)(6). COMPLAINANT COUNTRY: (B)(6). NAME OF AFFILIATION: (B)(6). BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A REPORTABLE MALFUNCTION. REGION: NORWAY PRODUCT / SYSTEM APPLICATION PRODUCT (SAP): 1704596 AQUACEL EXTRA 15X15CM (1X5PK STER EUR) LOT: 5J03762. DATE OF MANUFACTURE: 16 SEP 2025. BATCH SIZE: (B)(4) SECONDARY UNITS ((B)(4) PRIMARY UNITS). A COMPLAINT WAS RECEIVED FROM NORWAY REPORTING; ¿THE GASKET TEARS IN THE MIDDLE WHEN YOU OPEN THE GASKET, AND YOU CANNOT REMOVE THE PRODUCT STERILELY. THIS APPLIES TO 3 PCS W/LOT NO. 5J03762 AND 10 PCS W/LOT NO. 5K03394. CONSEQUENCE: WE CANNOT USE THESE DRESSINGS AS WE CANNOT GUARANTEE THEIR STERILITY WHEN THEY ARE REMOVED FROM THE PACKAGE. WE CANNOT APPLY AN UNSTERILE DRESSING TO A SURGICAL WOUND DUE TO THE RISK OF INFECTION. THE RESULT IS THEREFORE THAT WE HAVE TO OPEN NEW ONES. FOR MATERIAL 1704596 BATCH 5J03762, THE LOT WAS MANUFACTURED ON 16/SEP/2025. 03 PRIMARY UNIT WAS REPORTED AS IMPACTED FROM (B)(4) SECONDARY UNITS ((B)(4) PRIMARY UNITS). NO PHOTOGRAPHS WERE PROVIDED BY THE COMPLAINANT TO DEMONSTRATE THE REPORTED DEFECT. NO PHYSICAL SAMPLES WERE RETURNED TO CONVATEC FOR EVALUATION. THEREFORE, THE COMPLAINT CANNOT BE CONFIRMED, AND THE INVESTIGATION IS LIMITED TO RECORD REVIEW AND TREND ANALYSIS. A FULL BATCH RECORD REVIEW WAS COMPLETED FOR LOT 5J03762: ¿ ALL QUALITY CONTROL (QC) INSPECTIONS AND FINAL RELEASE ACTIVITIES WERE RECORDED AS ACCEPTABLE. ¿ NO MATERIAL-RELATED OR PACKAGING-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 AND PREVENTIVE ACTIONS (CAPA) (S) OR NONCONFORMANCES WERE RAISED IN RELATION TO PRODUCTION ORDER 1864527. NO PROCESS DEVIATIONS OR PACKAGING-RELATED NONCONFORMANCES WERE IDENTIFIED FOR LOT 5J03762. NO ADDITIONAL COMPLAINTS HAVE BEEN ASSIGNED TO BATCH 5J03762DURING THE 12-MONTH LOOKBACK. A BROADER MATERIAL-LEVEL REVIEW FOR MATERIAL 1704596 (AQUACEL EXTRA 15X15CM (1X5PK STER EUR)) IDENTIFIED THREE FURTHER COMPLAINTS WITH THE SAME MALFUNCTION CODE OVER THE PAST 24 MONTHS: ¿ A COMPLAINT IN DATABASE: ORIGINATION FROM SWEDEN FOR PRIMARY PACKAGING TEARING WHEN OPENED. MALFUNCTION PRIMARY PACK TEARS, RIPS OR SHEDS MATERIAL DURING OPENING (STERILE PRODUCTS), IMPACTING 1 DRESSING. A COMPLAINT IN DATABASE: ORIGINATION FROM NORWAY FOR ¿THE GASKET TEARS IN THE MIDDLE WHEN YOU OPEN THE GASKET, AND YOU CANNOT REMOVE THE PRODUCT STERILELY¿ MALFUNCTION: PRIMARY PACK TEARS, RIPS OR SHEDS MATERIAL DURING OPENING (STERILE PRODUCTS), IMPACTING 1 DRESSING. A COMPLAINT IN DATABASE: ORIGINATION FROM SWEDEN FOR ¿IT IS NOT OPENING AT THE SEAL, BUT TEARS OP AT THE SIDE INSTEAD, WHICH CONTAMINATES THE DRESSING AND MEANS IT HAS TO BE DISCARDED.¿ MALFUNCTION: PRIMARY PACK TEARS, RIPS OR SHEDS MATERIAL DURING OPENING (STERILE PRODUCTS), IMPACTING 1 DRESSING. THESE COMPLAINTS ARE ASSOCIATED WITH TEAR BEHAVIOUR DURING OPENING OF THE PRIMARY PACK, POTENTIALLY LINKED TO SEAL CHARACTERISTICS (E.G. INCREASED SEAL STRENGTH OR LOCALISED VARIATION ALONG THE SINE WAVE SEAL). ALL COMPLAINTS ORIGINATE FROM THE EUROPEAN REGION (SWEDEN AND NORWAY). THE AVAILABLE EVIDENCE INDICATES A LOW-FREQUENCY RECURRING DEFECT ACROSS MULTIPLE BATCHES, RATHER THAN A SINGLE BATCH-SPECIFIC OCCURRENCE. THE CURRENT COMPLAINT RELATES TO ONE PRIMARY PACK REPORTED WITH TEARING DURING OPENING. THE TOTAL BATCH SIZE WAS (B)(4) SECONDARY UNITS ((B)(4) PRIMARY UNITS). OF THESE, (B)(4) SECONDARY UNITS ((B)(4) PRIMARY UNITS) WERE DISTRIBUTED, WITH NO ADDITIONAL FEEDBACK OF SIMILAR ISSUES, AND (B)(4) UNITS REMAIN IN DISTRIBUTION CENTER (DC) INVENTORY WITHOUT REPORTED DEFECTS. GIVEN THE LOW OCCURRENCE RATE (03 REPORTED EVENT OUT OF (B)(4) SECONDARY UNITS ((B)(4) PRIMARY UNITS)), THE COMPLAINT FREQUENCY REMAINS LOW RELATIVE TO THE TOTAL DISTRIBUTED QUANTITY. A TOTAL OF THREE COMPLAINTS HAVE BEEN IDENTIFIED FOR THIS BATCH. BASED ON THE COMBINED DATA SET, THE RISK TO PRODUCT QUALITY AND PATIENT SAFETY REMAINS LOW, ALTHOUGH A RECURRING DEFECT MECHANISM IS INDICATED. ACROSS THE FULL MANUFACTURED POPULATION OF (B)(4) PRIMARY PACKS: ¿ A TOTAL OF (B)(4) PACK TEAR-RELATED COMPLAINTS HAVE BEEN RECEIVED ¿ BATCH RECORD REVIEW, IN-PROCESS INSPECTIONS, AND DEVICE HISTORY CHECKS IDENTIFIED NO DEVIATIONS, NO RECURRING ISSUES, AND NO PROCESS-RELATED TRENDS DURING MANUFACTURE ¿ THE OBSERVED DEFECT RATE (03 PRIMARY UNITS OUT OF 38400 PRIMARY PACKS = 0.008%) REMAINS BELOW THE NOTIONAL 0.40% ACCEPTABLE QUALITY LEVEL (AQL) LIMIT, CONFIRMING NO EVIDENCE OF AN AQL EXCURSION CORRECTIVE AND PREVENTIVE ACTIONS (CAPA) JUSTIFICATION. MULTIPLE COMPLAINTS HAVE BEEN IDENTIFIED FOR MATERIAL 1704596 (AQUACEL EXTRA 15X15CM (1X5PK STER EUR)) WITH MALFUNCTION (PRIMARY PACK TEARS, RIPS OR SHEDS MATERIAL DURING OPENING) ACROSS MORE THAN ONE BATCH (5K03394 AND 5J03762). THESE EVENTS, REPORTED FROM MULTIPLE REGIONS (SWEDEN AND NORWAY), DEMONSTRATE A CONSISTENT FAILURE MODE ASSOCIATED WITH TEARING OF THE PRIMARY PACK DURING OPENING, INDICATING A RECURRING ISSUE BEYOND A SINGLE BATCH. ALTHOUGH THE OVERALL DEFECT RATE REMAINS LOW RELATIVE TO THE TOTAL DISTRIBUTED QUANTITIES, THE RECURRENCE OF SIMILAR COMPLAINTS ACROSS MULTIPLE BATCHES INDICATES A POTENTIAL WEAKNESS IN THE SEALING PROCESS OR MATERIAL PERFORMANCE, PARTICULARLY ASSOCIATED WITH THE SINE WAVE SEAL AREA. IN ACCORDANCE WITH WORK INSTRUCTIONS (WI), A CAPA IS REQUIRED WHERE THERE IS EVIDENCE OF: ¿ RECURRING DEFECT SIGNATURES ACROSS BATCHES. ¿ POTENTIAL PROCESS OR MATERIAL-RELATED VARIATION. ¿ NEED FOR EVALUATION OF EXISTING CONTROLS. THEREFORE, A CAPA WILL BE RAISED TO: ¿ INVESTIGATE SEALING PROCESS PARAMETERS (TEMPERATURE, PRESSURE, DWELL TIME) ACROSS AFFECTED BATCHES. ¿ ASSESS MATERIAL CONSISTENCY AND SEAL INTEGRITY PERFORMANCE. ¿ REVIEW EQUIPMENT SETTINGS AND VARIABILITY (E.G. PMK LINE PERFORMANCE). ¿ EVALUATE INSPECTION AND RELEASE CONTROLS FOR DETECTION CAPABILITY. ¿ IMPLEMENT CORRECTIVE AND PREVENTIVE ACTIONS TO REDUCE RECURRENCE. AT THIS STAGE, THE ISSUE IS CONSIDERED A LOW-FREQUENCY RECURRING DEFECT ACROSS BATCHES, WITH NO EVIDENCE OF WIDESPREAD SYSTEMIC FAILURE, BUT REQUIRING FURTHER INVESTIGATION TO DETERMINE THE EXTENT AND ROOT CAUSE. THE BATCH REMAINS WITHIN SPECIFICATION AND ACCEPTABLE QUALITY LIMITS. THE ISSUE IS NOT CONSIDERED ISOLATED AND REFLECTS A RECURRING DEFECT ACROSS BATCHES REQUIRING CAPA INVESTIGATION. CAPA HAS BEEN RAISED TO DETERMINE THE ROOT CAUSE. THE COMPLAINT WILL CONTINUE TO BE MONITORED THROUGH ROUTINE TRENDING AND THE POST MARKET PRODUCT MONITORING REVIEW PROCESS (SOP-000741) 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.

Description of Event or Problem · 0

THE DISTRIBUTOR REPORTED THAT THE GASKET TORE IN THE MIDDLE WHEN THE PACKAGES WERE OPENED, WHICH PREVENTED THE PRODUCT FROM BEING REMOVED IN A STERILE MANNER. THE CUSTOMER DID NOT RECEIVE A DAMAGED BOX; HOWEVER, THE PACKAGING ITSELF TORE DURING OPENING. ALTHOUGH THE INTERNAL DRESSINGS WERE NOT PHYSICALLY DAMAGED, THE CUSTOMER WAS UNSURE WHETHER THE PRODUCTS REMAINED STERILE DUE TO THE TEARING OF THE PACKAGING AT THE TIME OF OPENING. SINCE STERILITY COULD NOT BE GUARANTEED, EACH AFFECTED DRESSING WAS CONDEMNED UPON OPENING AND COULD NOT BE USED ON SURGICAL WOUNDS BECAUSE OF THE ASSOCIATED INFECTION RISK. AS A RESULT, NEW DRESSINGS HAD TO BE OPENED, LEADING TO UNNECESSARY PRODUCT WASTAGE AND ADDITIONAL COST, AS THESE DRESSINGS ARE EXPENSIVE. NO PHOTO WAS AVAILABLE AT THIS TIME.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
478985	AQUACEL EXTRA	DRESSING, WOUND, HYDROPHILIC	NAC	CONVATEC LTD	420673	5J03762	00768455125630

Patients

Seq	Age	Sex	Outcome	Treatment
1	NA	Unknown