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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: foreign matter (e.G.Hairs, insects) within primary pack (sterile products), region: colombia, product / system application product (sap): 1714053 aqaucel foam pro sacral 24x21.5cm (1x5pk) nai, lot: 5a02959, date of manufacture: 20jan2025, complaint reference: record in database, sterilisation: (b)(4) 25jan2025, batch size: (b)(4) secondary units ((b)(4) primary) record in database was received from colombia reporting; ¿while attending to the patient and covering the wounds, the dressing was removed, revealing a sterile aquacel foam pro 21.5-24 dressing contaminated with what appears to be a hair.The contaminated dressing was not used but was saved as evidence and replaced with a new, undamaged one.¿ for material: 1714053 batch 5a02959.The lot was manufactured on 20jan2025 and sterilised under (b)(4) 25jan2025.(b)(4) primary units impacted from (b)(4) secondary units ((b)(4) primary) two photograph was provided by the complainant to demonstrate the reported contamination on one of the dressings.A hair on the adhesive polyurethane film (pu) border of the dressing.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 any images or physical samples, the depth of investigation is restricted, and a definitive root cause cannot be fully established and the complaint cannot be confirmed.A full batch record review was completed for lot 5a02959: 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 check sheets, were fully completed, dated, and signed in accordance with gross domestic product (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 additional complaints has been assigned to batch 5a02959¿ 12 month lookback.A broader material-level review for material 1714053 aqaucel foam pro sacral 24x21.5cm (1x5pk) nai identified no further complaints with the same malfunction code over the past 24 months.The current complaint relates to 01 primary pack reported with contamination.The total batch size was (b)(4) secondary units (equivalent to (b)(4) primary units).Of these, all units were distributed from distribution centres, with no additional feedback of similar issues, and no units remain in distribution center (dc) inventory without reported defects.Given the low occurrence rate (01 reported event (impacting (b)(4) primary packs) out of (b)(4) distributed 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 a the same malfunction code has been raised for this batch, there is no evidence of correlated deviations, common defect signatures, or recurring contamination mechanisms.Across the full manufactured population of (b)(4) secondary packs ((b)(4) primary units): no additional 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 acceptable quality level (aql) excursion.Based on work instructions (wi) risk assessment criteria, the event does not represent increased risk to patient safety, device performance, or regulatory compliance.In alignment with work instructions (wi), there is no evidence of a systemic failure mode, recurring defect signature, or risk escalation that would necessitate corrective and preventive actions (capa).Therefore, corrective and preventive actions (capa) is not required, and the complaint will continue to be monitored through routine post-market product monitoring and trend review processes.The optima line involves manual placement of exposed dressings onto the primary paper webpath, followed by manual visual inspection prior to primary pack sealing.Given the reported nature of the complaint (foreign matter described as hair) and the manual interaction with the product during this stage of manufacturing, personnel interaction represents a potential introduction pathway should contamination occur.As the hair is on the adhesive border under the ldpe liner.This suggests that the contamination occurred during the conversion of the dressing on the delta 2 line.Potential sources could include incidental hair shedding from personnel or inadequate management of personal protective equipment (ppe), such as hair nets or snoods, within the cleanroom environment during product handling.Visual inspection on the delta 2 and optima line is performed while the production line is in motion.Due to the small size and low contrast characteristics of potential hair contamination, detection may be challenging during dynamic inspection conditions at standard inspection distances.A review of the applicable inspection procedures and batch documentation identified no deviations from established inspection practices during the manufacture of the batch.A review of batch documentation confirmed no cleanroom pressure excursions or environmental integrity issues during the manufacturing period.Environmental monitoring results were within established control limits, and line cleaning documentation was completed in accordance with approved procedures, with no deviations recorded.Additionally, no gowning or good manufacturing practice (gmp) nonconformances were identified during the production period.A corrective and preventive actions (capa) record in database has previously been initiated in response to a separate complaint relating to hair contamination in database.This corrective and preventive actions (capa) addresses improvements to personnel gowning controls and contamination prevention practices.Planned actions under the corrective and preventive actions (capa) include: revision of the current gowning system and associated procedures to strengthen contamination control requirements.Reinforcement of good manufacturing practice (gmp) and gowning practices through targeted retraining of personnel.Implementation of periodic mandatory gowning retraining within the training management system to ensure continued compliance with cleanroom gowning requirements.A formal risk assessment of the gowning process to identify opportunities for improvement in contamination control and good manufacturing practice (gmp) enforcement.The corrective and preventive actions (capa) remains responsible for evaluating and implementing improvements to gowning controls and personnel practices to further reduce the potential risk of foreign matter contamination.The optima line is currently scheduled for updates for fully automated conversion, with a transition planned to a more automated manufacturing system.The future process will reduce manual handling of exposed dressings and incorporate enhanced inspection controls.This transition forms part of a planned continuous improvement initiative and is not related to the current complaint investigation.Based on the available information, the batch remains within specification and acceptable quality limits.The complaint relates to a single reported unit, with no supporting evidence available for verification and 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.No corrective and preventive actions (capa) is required.The complaint will continue to be monitored through routine complaint 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.
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