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Received two pictures for evaluation.The reported event was confirmed.During the visual evaluation of the photos, it was observed that the product was relabeled over the tyvek lid.The labels show different lot numbers.The original printing of the lot number was not included in the picture #1.The picture #2 shows the labeling of the case, no discrepancies were found.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: "ii.Device description: reliavac® 100 closed wound suction evacuator kits contain wound drains and evacuators.Wound drains are made up of silicone materials; they are round or flat shape with perforations.They are packaged with or without a trocar.Evacuators are made up of pvc materials.Iii.Indications for use: closed wound drainage following head and neck, abdominal, ent, ob/gyn, plastic surgery and neurosurgery.Iv.Contraindications: none known.V.Precautions: 1.Ensure that the wound site is dry and free of debris before closure.2.The surgeon must determine the number of drains needed for an effective drainage of the entire wound site.3.The junction between the tubing and tissue at the drain entrance site must be air-tight for effective functioning of the system.4.If the drain is occluded, irrigation and/or aspiration of the drain may be required.5.The quality and quantity of drained fluid must be regularly monitored and reported to the surgeon.6.Reservoir, once full, must be emptied per hospital protocols.Failure to do so will result in incomplete drainage.7.Suction must be discontinued prior to the removal of the drain.8.Before starting the drainage procedure, ensure that all the connections are tight and free of any obstructions within the drainage pathway.Connections to check are: i) drain to suction source.Ii) y-connector (when applicable): ¿ drain to y-connector ¿ y-connector to suction source.Di(2-ethylhexyl)phthalate (dehp) is a plasticizer used in some polyvinyl chloride medical devices.Dehp has been shown to produce a range of adverse effects in experimental animals, notably liver toxicity and testicular atrophy.Although the toxic and carcinogenic effects of dehp have been well established in experimental animals, the ability of this compound to produce adverse effects in humans is controversial.There is no evidence that neonates, infants, pregnant and breast feeding women exposed to dehp experience any related adverse effects.However, a lack of evidence of causation between dehp-pvc and any disease or adverse effect does not mean that there are no risks.Vi.Warnings: 1.An effective closed suction drain system requires maintenance of the system to preserve patency.The drain must not be allowed to occlude nor the reservoir to completely fill; and reservoir must be maintained in order for the system to function properly.If the system is not maintained properly, surgical complications including hematomas may result.2.Blood collected using the evacuator must not be re-infused as it may be a cause of potential infections.3.Do not use in patients who are allergic to materials used in bard® drain products.4.Do not bypass or inactivate the anti-reflux valve.5.In the event of occlusion of the drain, all wound drainage ceases.Careful attention to the drain will minimize the probability of this problem.If occlusion does occur, the drain can be aspirated by connecting suction to the reservoir outlet or temporarily disconnecting the drain from the evacuator and applying suction directly to the drain.6.If an air-tight seal between the drain and the skin (where the drain emerges) is not achieved, then air leak must be rectified or the system must be converted to open drainage.7.An airtight seal between all system components (drain, adapter, y-connector, crab-claw, evacuator and tube ends) is necessary for intended system function.8.Leaving the drain implanted for any period of time so as to cause tissue ingrowth around the drain can interfere with easy removal and may affect the performance of the drain.The surgeon should monitor the patient¿s rate of wound healing.9.Drain perforations must lie within the wound or cavity to be drained, otherwise inadequate drainage may result.10.To avoid the possibility of drain damage or breakage, please follow these steps: a.Avoid suturing through drains.B.Drains should lie flat and in line with the skin exit areas.C.Particular care should be taken to avoid any obstacles to the drain exit path.D.Drains should be checked for free motion during closure to minimize the possibility of breakage.E.Drain removal should be done gently by hand.Drains should not be handled with pointed, toothed or sharp instruments as these could cause cuts or nicks and lead to subsequent structural failure of the drain.F.Surgical removal may be necessary if drain is difficult to remove or breaks.11.This is a single use device.Do not reuse.12.Do not re-sterilize.Note: when using trocar with drain, care should be taken as the sharp and pointed edge of trocar could result in serious injury.After removal of trocar from the drain, please dispose of it as per the hospital protocol in the appropriate biohazard/sharps container.Vii.Complications: 1.This is a single use device.Do not resterilize any portion of this device.Reuse and/or repackaging may create a risk of patient or user infection, compromise the structural integrity and/or essential material and design characteristics of the device, which may lead to device failure, and/or lead to injury, illness or death of the patient.2.Severe allergic reactions or illness may result in patients who are allergic to materials used in bard® drain products.3.If the evacuator is not emptied when full, drainage from the wound site will cease and the likelihood of back-contamination across the anti-reflux valve is increased.4.In the event an air-tight seal is not achieved, the evacuator will rapidly fill with air from the leak; subsequent drainage to the evacuator will occur only if allowed by gravity and wound exudates forcing the flow.Entry into the evacuator is allowed only by displacement of air in the evacuator by wound exudates flow.In this displacement process, air reflux from the evacuator 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 ceases.5.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.6.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 patient degree of intolerance to any foreign object in the body.1.The surgeon should irrigate the wound with sterile fluid and then suction the irrigating fluid and gross debris from the operative site.2.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.3.Positioning of the drain in the body cavity, as well as the number of drains indicated, should be determined by the surgeon.4.Drain tubing should be placed within the wound by approximating the areas of critical fluid collection.5.Care must be taken to ensure that all drain perforations or channels lie completely within the wound or cavity to be drained.6.Taping or a triple loop suture (around and not through the tubing) will aid in preventing accidental drain placement.7.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.8.Care must be exercised to avoid damage to the drain (refer to warnings).The tubing should be repeatedly checked during closure for free motion to avoid breakage and/or fragment retention within the wound.9.When using a trocar please follow these instructions: 9.I.) with one drain: - draw drain using trocar from inside to outside of wound.- ensure that perforated section of the drain is within the critical fluid collection areas of wound.- remove trocar only by cutting the drain one inch from the end of the trocar.- trim non-perforated section of drain to desired length.- attach non-perforated section of drain either to an evacuator inlet port or to a y-connector.9.Ii.) with two single drains: - follow instruction# 9.I for each of the two drains separately.9.Iii.) with a double drain: - draw drain using trocar from inside to outside of wound.- ensure that desired perforated region of the drain is within the critical fluid collection areas of wound.- cut the outer portion of the drain (outside the wound area) in the middle of the perforated region.Attach non-perforated section of the inserted drain to an evacuator inlet port or to a y-connector.- after cutting (as mentioned above), the second half of this drain can be used separately.If you are not using the second half then dispose of it as per the hospital protocol.Viii.Instructions for use: 10.Attaching to auxiliary suction: 10.I.) connect suction tube to empty port using a stepped 5-in-1 connector.10.Ii.) during auxiliary suction evacuator will deflate and exudates will flow through evacuator into suction tube.11.To establish suction: 11.I.) open empty port.11.Ii.) squeeze evacuator.11.Iii.) close empty port.Note: reflux of fluid to the patient is minimized during reactivation by an anti-reflux valve in inlet port.12.To empty container: 12.I.) open empty port over collection basin.12.Ii.) squeeze evacuator to empty.13.To re-establish suction: repeat step 11 above.14.To read fluid volume: 14.I.) invert unit.14.Ii.) open empty port to release vacuum.14.Iii.) read and record approximate volume.14.Iv.) empty and reactivate evacuator.Important: a.Check for fluid entering closed wound suction evacuator.Lack of flow may indicate all exudate has been removed.B.When not using auxiliary suction during surgical wound closure, several activations of the closed wound suction evacuator may be required to establish suction because of the following: i.Air entering partially closed wound.Ii.An operative air pocket.C.The attached strap may be used to secure the evacuator to the patient.".
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