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Additional information - this emdr is being submitted to include the below: d9: device available for evaluation has been selected as yes & date returned to mfg was added as well.H3: device evaluated by manufacturer? has been selected as yes h6: investigation results under type of investigation, investigation findings, investigation conclusions, h11: investigation summary.Complaint code: foreign matter (e.G.Hairs, insects) within primary pack (sterile products).Region: south korea, product / system application product (sap): 1704595 aquacel extra 15x15cm (1x5pk) ster nai, lot: 5c03225, date of manufacture: 19 mar 2025, sterilisation: (b)(4) 25mar25, batch size: (b)(4).A complaint was received from south korea reporting; ¿hair in product: mfds requested it before returning complaint sample.¿ for material: 1704595 batch 5c03225.The lot was manufactured on 19/mar/2025 and sterilised under steris (b)(4) 25mar25.(b)(4) 08 photographs were provided by the complainant to demonstrate the reported contamination on one of the dressings.The physical samples were returned to convatec for evaluation.As the dressing was returned to the deeside a full analysis and hands-on assessment of the defect was performed.A full batch record review was completed for lot 5c03225.Batch record reivew: a full batch record review was completed for production order (b)(4), material 1704595, batch 5c03225 ¿ aquacel® extra 15 × 15 cm (1 × 5pk) ster nai.All recorded in-process and final quality control (qc) inspections were completed as defined and documented as acceptable, with no outstanding holds, rework, or conditional releases.Final release was confirmed in the record set, with no deviations from documented release criteria.Review of batch documentation confirms no material-related, foreign-matter, or contamination-related observations raised during compounding, coating, converting, or secondary packaging stages.No indicators of batch-specific handling, segregation, or housekeeping failures were identified.All required forms; ctq forms checksheets, were fully completed, dated, and signed in accordance with gdp expectations, with no evidence of missing data, overwrites, or retrospective corrections.No non-conformance, supplier corrective action report (scar), scrap action, or quality incident was raised during execution of order (b)(4).No corrective and 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 5c03225.Batch trend for 5c03225: no other complaints have been raised for batch 5c03225.The reported contamination involves one primary units within a single complaint, with no evidence of recurrence or clustering for this batch.Material trend- material: 1704595 ¿ aquacel extra 15x15cm (1x5pk) ster nai: 12 month look back: a complaint ¿ batch 5a05302, raised 28-nov-2025 (currently on query status).The complaint was initially classified as foreign body.However, further review indicates the observed issue is consistent with additional / unintended print associated with the 2d udi print (wolke) rather than a true foreign body.Based on this assessment, the malfunction may align with another complaint (foreign matter within product, sterile products (e.G.Metal contamination in dressings, particulates within fluids, gels etc)).This classification is currently under challenge, and additional supporting evidence is required to confirm whether the observed marks are attributable to excess or mis-applied udi print.At this stage, the issue appears to be printing-related, pending confirmation through further investigation and evidence review.Pmk line trend for contamination: a complaint in database ¿ batch 5c03225 (current complaint).A complaint in database ¿ batch 5a05302 (highlighted in 12 months look back) print issue- raised 28-nov-2025.A complaint in database ¿ batch 2b00546 (highlighted in 24-month lookback) red splicing tape ¿ raised 27march 2024.Across the 24-month lookback, only one confirmed contamination event was identified on the pmk line, recorded under malfunction.The remaining events were either printing-related in nature or remain under investigation and are not indicative of a systemic contamination trend.There is no evidence of recurring contamination mechanisms, common causal factors, or process failures on the pmk line.Based on the low frequency, lack of repeat failure mode, and absence of a consistent contamination source, the current complaint is assessed as an isolated occurrence rather than part of an adverse trend.Aql and rates: batch size (b)(4).As per general inspection, the required inspection level for contamination for a batch of this size is aql (b)(4), using an accept = 5 / reject 6 sampling plans for a sample size of 500 units, for batch size (b)(4).The appropriate inspection regime was applied at manufacture through routine in-process and end-of-line checks.The acceptable quality level (aql) sample taken did not exceed the rejection threshold.The observed defect rate (b)(4) remains below the notional (b)(4) aql limit, supporting that manufacturing inspection results remained within established acceptance criteria, with no indication of loss of process control.No additional similar complaints have been identified across distributed units.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 the current complaint relates to one primary pack reported with contamination.The total batch size was (b)(4).All stock has been distributed from distribution centres, with no additional feedback of similar issues.Given the low occurrence rate (b)(4), the complaint frequency remains low relative to the total distributed quantity.The available evidence does not suggest a systemic or batch-wide manufacturing issue.Capa was raised to perform an indepth investigation and provide root cause for the contaminated dressing: complaint finding is associated to the below manufactured products at the deeside manufacturing site.Primary pack - pmk process: 5c03225 (1704595 ¿ aquacel extra 15x15cm (1x5pk) ster nai), time: 13th mar 2025 - 21st mar 2025, stitched reelstock ¿ advanced stitch bonder 3 process (asb3): 5b04735 (1705386 - reelstock aquacel extra sb 150mm) 1823770, time: 11th mar 2025 ¿ 16th mar 2025, textile process ¿ textile line 5 (tl5): 5b03609 (1721067 - reelstock aquacel 70gsm 900mm ils) 1816764, time: 27th feb 2025 ¿ 28th feb 2025.No other complaints have been raised for batch 5c03225.The reported contamination involves one primary units within a single complaint, with no evidence of recurrence or clustering for this batch.Nature of complaint is not-continuous (not manufacturing process related) and can be treated as isolated incident.There is potential for foreign matter contamination of this type across all manufacturing processes however there is no indication this is a systemic issue.Product manufactured on textile line from 27th feb 2025, followed by stitch bonder process 11th mar 2025 (foreign matter is stitched in to the material indicating this was the point that foreign matter was introduced, as hair has been stitched under the yarn).Product completed manufacture on pmk conversion & primary packaging process 21st mar 2025.Electron microscopy confirmed the origin of the contamination as human hair.The presence of the foreign matter within the internal structure of the dressing confirms that the contamination occurred prior to primary packaging and is not attributable to post-packaging or distribution activities.From the investigation: potential root causes identified: 1) gowning process not strictly adhered to (potential cause, unable to verify) - man - application errors.2) gowning process does not cover all hair on body* - method - procedures not adequtely defined.The investigation indicates that the contamination was introduced during the stitch bonding process, as the foreign matter was embedded within the structure of the material.However, the specific point of introduction and exact cause (e.G.Specific gowning breach or event) could not be conclusively verified.Hair is a potential contamination source in all manufacturing areas - environments are class 8 and gmp / gowning processes are designed to reduce risk, but are not able to eliminate risk of hair contamination.Existing gowning arrangements do not control eyebrow / eyelashes.All products are terminally sterilised for this reason.*in existing manufacturing strategy (class 8 environments with terminal sterilisation) it is not feasible to cover all hair on body or prevent all source of contamination.From the investigations the following actions were established: corrective actions: 1) revise gowning procedures to include visual guidance on fitting of beard snoods & hair nets.2) reinforce gmp & gowning training through retraining.3) schedule periodic mandatory retraining in training management system.4) risk assessment to identify opportunities for improvement in gowning processes & gmp enforcement for contamination control.Effectiveness action: 1) complete good manufacturing practices (gmp) audit in all manufacturing units - verify compliance to gowning requirements.2) retrospective analysis of non-conformance (nc) / capa system since action.Implementation - confirm recorded occurrences of hair contamination is within (b)(4) aql there was no evidence of a systemic failure mode, recurring defect signature, or adverse trend that would indicate loss of process control.Capa raised to investigate the root cause of the complaint.Further monitoring of the impacted batch through routine post-market product monitoring and trend review processes.The capa remains responsible for evaluating and implementing improvements to gowning controls and personnel practices to further reduce the potential risk of foreign matter contamination.Based on the available information, the batch remains within specification and acceptable quality limits.The complaint relates to a single reported unit.The complaint relates to a single confirmed unit, supported by photographic evidence and returned sample analysis, with no additional complaints identified for the batch or material during the review period.The issue is therefore considered isolated, with no indication of systemic manufacturing failure or recurring contamination mechanism.Capa required.The complaint will continue to be monitored through routine complaint trending and the post market product monitoring review process (sop-000741).
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