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The reported event was confirmed cause unknown.The exact root cause could not be identified.Although a root cause could not be definitively identified, based on the risk documentation review, a potential root cause for this type of failure could be wall thickness too thin.However, there was insufficient information to confirm this potential root cause.Two photos were received.The first one shows an overview of the 2-way all-silicone foley catheter and the second photo zooms into the catheter balloon and tip, with a red arrow pointing at the balloon.It was also received 1 all-silicone foley catheter.It was attempted to inflate the balloon with 10 ml of methylene blue solution (3 drops 1% aq methylene blue per 100ml distilled water) and a leak was observed in the balloon.Further inspection evidenced a cut measuring 0.0940 in in the balloon.This is out of specification which states "balloon must not be torn.".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: "bardex® silver lubri-sil® foley catheter system [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, damage, etc.Before inserting a new catheter.Fragments of the balloon or segment of catheter may 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.· caution should be exercised in the following patients: · 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.The re 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.[prohibited concomitant use] 1.Do not use ointments, contrast medium or lubricants having oily base, including the mineral oil such as white petroleum, vegetal oil such as olive oil, or animal oil and fat.They will damage catheter 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 principle s] bardex® silver lubri-sil® foley catheter system consists of a balloon catheter, syringe prefilled with sterile water, and water-soluble lubricant. catheter: silicone; silver coating this product is made with bacti-guard®* silver alloy coating.[indications for use] this device is an indwelling catheter in the bladder for urinary drainage.The surface of catheter is coated first with a trace amount of metallic silver, and then with polyurethane onto that, to inhibit proliferation of bacteria that may adhere to the catheter.[instructions for use] 1.Cleanse the area around the external urethral meatus with the cotton balls immersed in the antiseptics.2.After opening the package, care should be taken to avoid contamination.Lubricate the shaft of catheter.3.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.4.Pull catheter slightly to seat the balloon at the level of the bladder neck.5.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.[precautions] 1.Precautions for patient application · 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 and 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.* foley catheter with 30ml printed cap use 30ml 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.· since movement of the body, etc.May twist or bend catheter to cause occlusion, care should be taken to fix the catheter securely.· after placement of the catheter, confirm urinary flow through the catheter.When urinary flow cannot be noted, confirm that the catheter is neither occluded nor broken.If the problem is still observed, consider catheter replacement.· 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 * 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.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.(fig.2) insert an indwelling needle of appropriate caliber into the inflation lumen, and retry gentle pumping, if necessary.(fig.3) 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.(fig.4) * 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 of 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.7) c) in female patients, since the urethra is straight and short, burst the balloon by insertion of a long needle along the urethra.(fig.8) 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 c ontamination · 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, preferably in the original box.2.Expiration date: indicated on the direct package and the outer box.[packaging] 10 pieces per box" correction: d,f,h,g 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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