|
The reported event was inconclusive because no sample was returned.A potential root cause for this failure could be "wall thickness too thin".The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: ¿[warnings] method for use: when catheter is inadvertently removed, inspect the balloon and shaft of catheter for rupture, defect, etc.Before inserting a new catheter.[fragment of the balloon or segment of catheter may remain in the bladder.] do not pull the catheter hard.[the catheter including a balloon may be damaged or the bladder/urethral mucous membrane may be injured.] 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¿.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.] when inserting catheter with a stylet, confirm that the stylet has reached the tip of the catheter, and make sure to keep the stylet in place inside the catheter during insertion.[the stylet may exit the side hole to damage the urethral mucosa.] applicable 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] method for use: do not reuse.Do not resterilize.Be careful that the catheter is not exposed to ointments, contrast medium or oil-based lubricants (including vegetable oils such as olive oil, mineral oils such as white petrolatum and animal oils).[they may damage the device and may burst balloon.] do not hold the device with forceps, etc.Avoid contact with any blades or sharp-edged instruments.[catheter damage may cause balloon rupture and accidental balloon removal or failure to deflate or remove the balloon.] 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] balloon catheter: silicone product numbers, sizes etc.Relevant to this package insert are shown in package labeling.1.Balloon catheter with temperature-sensing [intended use & effect- efficacy] this device is an indwelling catheter in the bladder for urinary drainage.[directions for use] 1) method of use the device is intended for single use only and is not reusable.2) precautions for use 1) cleanse the area around the external urethral meatus with the cotton balls immersed in the antiseptics.2) lubricate catheter shaft with water-soluble lubricant.3) carefully insert catheter into the urethral meatus, and advance it until the balloon enters the bladder.Using a needleless syringe, and gently infuse the specified volume of sterile water into the valve to inflate the balloon.Never inflate the balloon without first establishing urine flow which assures that the catheter is in the bladder and there are no obstructions to urine flow.4) pull catheter slightly to seat the balloon at the level of the bladder neck and secure placement.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 use (exercise caution when using the device in the following patients) exercise caution when using the device in patients with high urinary calcium levels as encrustation on the balloon surface, catheter occlusion or damage may occur.2.Important 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.This product is a disposable, supplied sterile.If package is opened or expiration date has passed, do not use.Do not resterilize.For instructions regarding other medical equipment and/or medication used in conjunction, refer to the appropriate manufacturer ifus.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, use sterile water of the prescribed capacity labeled on the valve.If the valve is labeled as 5 ml/cc, use 5 ml, if 10 ml/cc, use 10 ml, if 30ml/cc, use 30ml of sterile water.Do not aspirate urine through drainage funnel wall.Since movement of the body, etc.May twist or bend catheter to cause occlusion, care should be taken to fix the catheter securely.When urinary flow cannot be noted, confirm that the catheter is neither occluded nor broken.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) if sterile water in the inflation lumen does not easily drain, do not aspirate with the syringe.Instead, leave it attached to the valve and allow time to wait for spontaneous drainage.Never pull on the syringe.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.(fig.1) fig.1 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) fig.2 fig.3 5) if situation wouldn't be improved with 4), insert a fine steel wire through the inflation lumen of catheter.(fig.4) fig.4 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.(fig.5 fig.5 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.(fig.6) fig.6 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) after removal with the balloon rupture method, the balloon should be carefully inspected for any fragments detached from the catheter.If any possibility of a retained balloon fragment exists, consider removing them using a cystoscope.3.Malfunction and adverse events 1) malfunction: catheter kinking, damage, rupture.Difficulty or failure to remove the device.Occlusion of catheter inner lumens.Encrustation.Accidental removal of the device due to leakage of sterile water or balloon rupture.Device damage due to inappropriate use.2) adverse events: urinary-tract infection.Hemorrhage, hematuria.Allergy reaction to the device.Calculus formation.Edema.Pain.Discomfort.Injury of bladder or urethral.Urethritis, urinary incontinence.Retained balloon fragments.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 in a dry, cool place avoiding direct sunlight.2.Expiration date: indicated on the direct package and the outer 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.
|
