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Submit date: (b)(6) 2018.The incident sample has been requested but to date has not been received for evaluation.If the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.
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A review of the device history records (dhr) for lot number 816323x, indicates product and specification requirements were met with no non-conforming product identified relating to this customer report.No adverse conditions, special circumstances, or events were documented that may have led to the gel delamination and/or skin irritation.All process parameters, product, raw materials, and sub-assembly components met the required acceptance criteria to completely satisfy the manufacturing requirements per the product specification.In addition, dhrs were reviewed for the hydrogel body subassembly utilized in this product.The production lot numbers for hydrogel body sub-assembly lot number did exhibit some minor aesthetic delamination.Aesthetic delamination will not significantly affect electrode function.These lots did not exhibit functional delamination, which is a permanent separation of the hydrogel from the substrate such that the silver/silver chloride ink remains exposed.The dhr¿s for the hydrogel body sub-assemblies met all acceptance criteria.Raw material records were reviewed as well and all acceptance criteria were met.The uv dosage outputs for curing the hydrogel bodies were within the proper range.The conductive silver/silver chloride ink and gel batch mix sheets were also reviewed.All components and mix time were within tolerance.A lot cannot be released unless it passes all quality and conformance requirements.In-process procedures are also in place to prevent nonconforming product in the manufacturing process.This ensures components and finished products meet all quality inspection standards.These controls include, but are not limited to: material verification/certification processes, dimensional specifications, statistical samplings, periodic audits, process inspections, machine maintenance/operation and personnel training and certification.This type of event is commonly referred to gel delamination.Gel delamination occurs when the gel-to-release liner bond strength is greater than the cohesive strength of the gel or greater than the gel-to-substrate bond strength.Such an inequity in bond strength can cause the gel to peel from the substrate and/or tear.Delamination is categorized as follows: an aesthetic delamination defect is characterized by a permanent separation of the hydrogel from the substrate, exposing the underlying carbon vinyl with little (i.E.Area less than 1/8 inch x 1/8 inch) or no hydrogel remains on the release liner.Also, no silver/silver chloride ink is exposed.Aesthetic delamination defects will not significantly affect electrode function, but may displease the clinician.Functional delamination is a permanent separation of the hydrogel from the substrate such that the silver/silver chloride ink remains exposed.Additionally, per the defibrillation electrodes design, there shall be no less than 55% hydrogel remaining on the adult electrode when the release liner is removed from the electrode.There shall be no less than 78% hydrogel remaining on the adult electrode, when the area of separation includes the area of underlying conductive mat.With loss of the hydrogel no more than the percentages as defined above the electrodes retain functionally essential performance; however the reduction in the hydrogel area with the silver/silver chloride ink being exposed may cause an increase in current density across the remaining gel area.This increases the potential for skin irritation and burns.Six (6) samples were received from the customer for evaluation.Four (4) of the electrode pouches (open) were also provided.The labels on the pouches indicated lot number 816323x.Upon visual inspection of the electrode pad sets it was noted that a small portion of the gel was missing/lifted from substrate along the edge on some of the electrode pads.In three sets (3) both pads within the set exhibited gel delamination.On other three (3) sets at least one pad per set exhibited gel delamination with the other pad was fully intact.The delamination did extend slightly into the silver printed area on one electrode set (one pad), and it did not include conductive mat area.The degree of delamination on the electrode sets were evaluated as part of the investigation.The degree of gel separation/delamination was determined be between 0.5% to 3.2% (96.8%-99.5% of gel remained intact).The gel delamination was within 55% minimum hydrogel separation from the adult electrode criteria.Five (5) production retains (5 sets) for lot number 816323x were also evaluated for gel delamination.No delamination was observed.Based on the complaint description provided and the investigation gel delamination described by the customer (customer supplied samples & production retains did not exhibit gel delamination) could not be confirmed as related to the manufacturing process.The following potential root causes related to manufacturing were evaluated and could not be confirmed.If the gel is insufficiently cured (the strength of the bond between the gel and the substrate was too weak) or there was insufficient silicone on the mylar liner (the strength of the bond between the gel and the plastic liner was too strong) delamination can occur, however none of the production records or incoming inspection records indicate this occurred.Another potential root cause related to manufacturing is that the silver ink re-mixing was not adequately performed during the sub-assembly printing process.If the silver ink is not adequate it may not properly dry which could result in gel not properly adhering to the silver printed substrate.This may contribute to gel delamination.Silver mixtures can become separated over time because they are suspensions; this is visually detectable prior to use.If re-mixing is required the machine operator documents this process occurred and that the silver mixture met the required acceptance criteria.A review of the production records indicated that silver re-mixing was not required.Additionally, gel delamination is possible if the defib electrodes are not properly stored.As indicated on the product packaging proper storage and usage of the electrodes is critical to the performance of the gel.The electrodes should be stored in their sealed protective pouch in a cool, dry place and out of direct sunlight.Do not open package until ready for use.Do not bend, fold, or puncture the packaging.Improper storage conditions and/or handling of the product may compromise gel properties prior to the expiration.The environmental and handling condition in which the product was stored was not provided with the complaint.The reported customer complaint is confirmed.A root cause could not be determined.No corrective or preventive action is planned at this time.This complaint will be used for trending purposes.
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The initial regulatory report was inadvertently submitted with the incorrect medical device number.The following sections have been updated with the accurate information: section d4, model number and catalog number: updated from 22550a to 22550r.Section d4, unique identifier: added udi number (b)(4).
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