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The reported event is confirmed - cause unknown.A potential root cause for this failure could be imperfection in balloon due to process.Received two (2) photo samples.Both photo samples showcase an overview of an all-silicone temp sensing foley catheter.Received one (1) used all-silicone temp sensing foley catheter without original packaging.Visual inspection noted no obvious observations.The catheter balloon was inflated with 10 ml methylene blue solution (3 drops 1% aq methylene blue per 100ml distilled water) and and the solution leaked out from 0.11" pinhole on balloon.This is out of specification which states, catheter leaks, valve leaks, balloon perforation, lumen to lumen, prematurely deflated and dislodged balloon are not allowed, and must inflate and deflate with the use of a syringe.A review of the device history record did not show any problems or conditions that would have contributed to the reported issue.The instructions for use were found adequate and state the following: ¿single use only [warnings] - method for use 1.Since it may be difficult to remove catheter even after balloon deflation in some cases, the catheter should be removed under the physician¿s instructions by reference to the section ¿troubleshooting¿.2.When deflating balloon, allow balloon to deflate on its own; do not aspirate with a syringe.The inflation lumen for balloon deflation may be occluded by negative pressure, and as a result the balloon cannot be removed.3.When catheter is inadvertently removed, inspect the balloon and shaft of catheter for rupture, defect, etc.Before inserting a new catheter.If visible defect of the balloon or segment of catheter, inspect fragments of catheter may not remain in the bladder.4.When inserting catheter with a stylet, confirm that the stylet has reached the tip of the catheter, and then insert without pulling them back.Otherwise, the stylet may exit the side hole to damage the urethral mucosa.- applicable patients 1.Use with great care for patients with disturbance of consciousness, etc.When patient removes catheter unconsciously, the mucosa of the bladder and urethra may be damaged, balloon may be ruptured, catheter may be broken, and catheter fragments may be left behind in the bladder.[contraindications & prohibitions] - method for use 1.Do not reuse.2.The balloon and shaft of catheter should not be pinched with forceps, etc.And avoid contacting the catheter with a blade or sharp-edged devices.There is a strong likelihood that breakage or inadvertent removal of catheter, or rupture of balloon will occur, and that inability of balloon to deflate may make removal of the catheter difficult.3.Aggressive traction, particularly in the presence of tape or suturing, is not recommended for 100% silicone foley catheters.- applicable patients 1.Patients with a past history of allergic hypersensitivity to povidone-iodine or iodine.[prohibited concomitant use] 1.Do not use ointments, contrast medium or lubricants having a petrolatum base on catheter (including oil of animal or plant origin, such as olive oil and petroleum jelly, and mineral oil).They will damage latex and may cause balloon to burst.2.Do not wipe catheter surface with organic solvents such as alcohol.3.No substance except sterile water should be used to inflate the balloon.If contrast medium is used, balloon may burst.If normal saline is used, crystallized salt may occlude the inflation lumen to prevent deflation of the balloon.If air is used, air may escape to cause inadvertent deflation of the balloon so that the catheter may come out prematurely.[shape, configuration and principles] bard® silver lubri-siltm foley tray consists of a balloon catheter, urine-collecting bag for closed drainage system, syringe prefilled with sterile water, water-soluble lubricant, antiseptic solution, tweezers, waterproof sheet, gauze pads, cotton balls and vinyl gloves.There are several types of closed drainage bag.The bag included in the tray will depend on the product.1.Foley catheter 2.Accessories [intended use & effect- efficacy] this device is an indwelling catheter in the bladder for urinary drainage [directions for use] 1) to secure sterile field for the procedure, spread a clean wrapping paper first.2) place waterproof sheet beneath patient¿s buttocks.(fig.1) 3) put on sterile gloves.Open tray and place it on the wrapping paper.4) cleanse the area around the external urethral meatus with the cotton balls immersed in the antiseptics.5) lubricate catheter by water-soluble lubricant packaged in the tray.6) carefully insert catheter into the urethral meatus, and advance it until the balloon enters the bladder.Using a syringe packaged in the tray, gently infuse the specified volume of sterile water into the inflation lumen to inflate the balloon.Inject entire amount of water contained in the syringe.Water should not remain in the syringe after infusion.7) pull catheter slightly to seat the balloon at the level of the bladder neck.8) after secure placement of catheter in the appropriate position, fix the drainage bag to the bed properly.(fig.6) 9) fix the outlet tube of drainage bag to the bed sheet using clips to ensure that there is neither twist nor kink in the tube.10) to deflate balloon and remove catheter, gently insert a luer tip (needleless) syringe in the inflation valve.Even without aspiration, sterile water in the balloon will come out spontaneously through balloon deflation.After balloon deflation, withdraw the catheter slowly while confirming that no abnormal resistance is encountered. foley catheter and outlet tube of the drainage bag are pre-connected, and connecting parts are covered with red seal (tamper-evident seal), which makes separation visible if they are disconnected.The seal prevents unnecessary and inadvertent separation of catheter a nd drainage bag as well as entry of bacteria into the drainage system.If it is necessary to disconnect catheter and drainage tube, flex catheter a little as illustrated, grasp tab at the end of the tape, and pull along perforations until the section is removed. bard ez-loktm sampling port accepts a luer-lock or slip tip syringe.Note: do not penetrate the ez-loktm sampling port with a needle.1) kink drainage tubing a minimum of 10 cm below the sampling port until urine is visible under the access site.2) swab surface of site with antiseptic wipe.3) using aseptic technique, position the syringe in the center of the sampling port.The syringe should be held perpendicular to the surface of the sampling port (at approximately 80-100 degree angle).Press the syringe firmly and twist gently to lock the syringe onto the sampling port.(fig.9) note: improper penetration technique could cause formation of a drop of urine on the surface of the sampling port.Periodic observation of the sampling port is recommended.4) aspirate desired volume of urine.5) unkink tubing and send specimen to laboratory.[precautions] 1.Precautions for patient application ¿¿povidone-iodine or iodine may cause shock and allergic symptoms including dyspnea, discomfort, edema, redness, urticaria, etc.When such symptoms appear, use of the device should be stopped immediately, and consult the attending physician so that appropriate measures should be taken.¿¿when this device is used for patients with a high urinary calcium value, adhesion of calcium to the external surface of balloon and occlusion of the catheter may occur.2.Important basic precautions ¿¿read all instructions for use prior to use a nd follow them.¿¿this product is a medical device for qualified physicians, and should not be used for any other purpose.¿¿the law restricts this device to sale by or on the order of a physician.¿¿this product is a disposable, supplied sterile.If package is opened or expiration date has passed, do not use.Do not resterilize.¿¿use the product in a sterile environment.¿¿for instructions regarding other medical equipment and/or medication used in conjunction, refer to the appropriate manufacturer ifus.¿¿use this device immediately after opening the package.After use, handle and dispose of in accordance with accepted medical practice and applicable regulations.¿¿when abnormal resistance is encountered in inserting catheter, do not use excessive force, and remove the catheter to find out the cause of difficulty in insertion.¿¿when inflating balloon with sterile water, do not exceed recommended capacities printed on the cap.Otherwise, the balloon may burst or be unable to deflate.* foley catheter with 10ml printed cap use 10ml sterile water.¿¿when inflating or deflating balloon with sterile water, use a luer tip (needleless) syringe.Do not use a needle.¿¿do not aspirate urine through drainage funnel wall.This may cause malfunction of catheter, or urinary tract infection.¿¿do not penetrate the ez-loktm sampling port with a needle.¿¿since movement of the body, etc.May twist or bend catheter to cause occlusion, care should be taken to fix the catheter securely.¿¿never inflate a balloon without first establishing urine flow which assures that the catheter is in the bladder and there are no obstructions to urine flow.¿¿to inflate or deflate the balloon, use a luer tip (needleless) syringe.In deflate the balloon, do not aspirate or manually accelerate the deflation of the balloon.If difficult to come out the water spontaneously, refer to ¿troubleshooting¿ as follows. when it is difficult to remove catheter by deflating the balloon (expressed as ¿removal-difficult case¿ hereinafter), take appropriate measures according to the following procedures under urologist¿s guidance.The following two methods are available for removal-difficult cases.A.Non-rupture method (sterile water is withdrawn without bursting the balloon.) b.Balloon-rupture method note: with balloon-rupture method, fragments of the ruptured balloon are more likely to be separated from catheter to remain in the bladder.Therefore, try non-rupture method first.A.Non-rupture method 1) even if you notice difficulty in removal of sterile water in the inflation lumen, do not attempt to aspirate the water with syringe at this stage.In such a case, re-seat the syringe and let it stand for a while to allow spontaneous deflation of the balloon.2) if situation wouldn't be improved with 1), inject an additional amount of sterile water into the inflation lumen.3) if situation wouldn't be improved with 2), sever the inflation funnel of valve to let out sterile water.(fig.10) 4) if situation wouldn't be improved with 3), sever the extracorporeal part of catheter while fixing it with a kocher, etc.So as not to push the cut end into the urethra.Insert an indwelling needle of appropriate caliber into the inflation lumen, and retry gentle pumping, if necessary.5) if situation wouldn't be improved with 4), insert a fine steel wire (such as a mandrin ureteral catheter) through the inflation lumen of catheter to let out sterile water.Note: even if the catheter cannot be easily removed with the non-rupture method, the attending physician may observe the patient for several hours by stabilizing the patient aseptically, and then try the non-rupture method once again at their discretion.This can apply if the patient¿s condition is stable, and he/she has no problem in urination.Even if the inflation lumen is severely crushed (which is the cause o f removal-difficult case), the crushed part may possibly return to the normal shape after a while, leading to relatively easy removal of the catheter.B.Balloon-rupture method 1) the balloon is allowed to burst by injection of a large amount of water.100-200 ml/cc of lukewarm water or physiological saline is infused into the bladder in advance, and after rupture of the balloon, the inside of the bladder is irrigated thoroughly for prevention of chemical-induced inflammation.2) if situation wouldn't be improved with 1), attempt following procedures.A) under the radioscopic observation, infuse a contrast medium into the bladder, and burst the balloon by suprapubic puncture of the bladder.B) in male patients, while confirming the location of the balloon under ultrasonographic guidance, burst the balloon by puncture with a long needle from the perineal (or suprapubic) region or through the rectum.(fig.16) c) in female patients, since the urethra is straight a nd short, burst the balloon by insertion of a long needle along the urethra.Note: with the balloon rupture method, the balloon should be examined whether rubber fragments have been split off from the catheter.In some cases, fragments should be removed using a cystoscope.3.Malfunction and adverse events ¿¿difficulty during catheter removal due to non-deflator balloon ¿¿inadvertent catheter dislodgement due to damaged catheter and/or balloon burst 4.Precautions for infection or contamination ¿¿visually inspect the product for any imperfections or surface deterioration prior to use.If package is opened or damaged or if any imperfection or surface deterioration is observed, do not use.¿¿use this device immediately after opening the package.After use, handle and dispose of in accordance with accepted medical practice and applicable regulations.[storage method and expiration date] 1.Storage: store catheters at room temperature away from direct exposure to light.2.Expiration date: indicated on the direct package and the outer box.[packaging] 10 pieces per box or 5 pieces per box¿ h11: section a through f - the information provided by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.H3 other text : the actual/suspected device was inspected.
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