Received a photo showing 1 unopened package and 1 opened package of channel drains.The reported issue was confirmed as manufacturing related.Per visual evaluation of the received photo (showing two packages) was impossible of confirm that the two samples correspond to one piece channel drain 24fr.However, per previous complaints received where the issue reported of ¿incorrect instructions¿ was confirmed as the same lot number: ngaz3014, therefore, the issue reported in this customer complaint file is confirmed.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use state the following: " reorder #: drain size: drain shape: fluting trocar: depth indicator: v072230 19 fr., round hubless, full, ¿, dot.V072234 24 fr., round hubless, full, ¿, dot.For use with 100cc, 200cc, 400cc, and 3-spring evacuators.Indications: round silicone channel drains are indicated for use with selected evacuators for closed wound drainage following head and neck, orthopedic, abdominal, ent, ob/gyn, plastic, neurosurgery, thoracic and cardiovascular (channel drains only) procedures.Complications: complications which may result from the use of this suction drainage system include the risks associated with methods utilized in the surgical procedure, as well as the patients degree of intolerance to any foreign object in the body.The advantages of wound drainage, particularly closed system drainage, are lost if an air-tight seal between the drain and the skin where the drain emerges is not achieved, or if the drain is allowed to become occluded or if the reservoir is not activated properly, doesn¿t function properly or is not monitored.Evacuators should be emptied and re-activated when required per hospital protocol.In the event an air-tight seal is not achieved, the reservoir will rapidly fill with air from the leak; subsequent drainage to the reservoir will occur only if allowed by gravity and wound exudate forcing the flow.Entry into the reservoir is allowed only by displacement of air in the reservoir by wound exudate flow.In this displacement process, air reflux from the reservoir to the wound can occur and increase the likelihood of back-contamination across the anti-reflux valve.In the event of drain occlusion by fibrin, clots, or other particulate matter, all wound drainage via the drain ceases.If the reservoir is not emptied when it is full, equilibrium between the drain and reservoir at wound pressure will ultimately occur and drainage from the wound site will cease.When the reservoir and drain are at the same pressure and the reservoir is full of fluid, the likelihood of back-contamination across the anti-reflux valve is increased.When used to drain the pleural cavity in the presence of an air leak, drains must be attached to an appropriate pleural cavity drainage system to prevent tension pneumothorax.Drain placement: ¿ the surgeon should irrigate the wound with sterile fluid, then suction the irrigating fluid and gross debris from the operative site.¿ tubes should lie flat and in line with the anticipated skin exit.To facilitate later removal by manual traction, the tubing should not be curled, pinched, or sutured internally.¿ positioning of the drain in the body cavity, as well as the number of drains indicated, should be determined by the operating surgeon.¿ drain tubing should be placed within the wound by approximating the areas of critical fluid collection.¿ care must be taken to ensure that all drain perforations or channels lie completely within the wound or cavity to be drained ¿ taping or a triple loop suture (around and not through the tubing) will aid in preventing accidental drain displacement.¿ deep drainage is best accomplished by using one or more drains for each level of tissue.Each level should be evacuated by a separate vacuum source.¿ care must be exercised to avoid damage to the drain (see warnings).The tubing should be repeatedly checked during closure for free motion to avoid breakage and/or fragment retention within the wound." (b)(4).
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