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The reported event was confirmed, however the cause was unknown.Based on the evaluation it was noted that irregular balloon burst was observed.No pieces of sac were missing.The sample was evaluated under microscope and no conditions were found that could be associated with the reported event.The exact cause could not be determined.A potential root cause for this failure mode could be due to a user related (example: contact with sharp objects / exposed to petrolatum based products / mechanical failure/operator error).The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: "[warnings] 1.Method for use: (1) do not inflate the balloon in the urethra.(the urethra may be injured) (2) do not pull the catheter hard.(the bladder/urethra maybe injured) [contraindications] 1.Method for use: (1) do not reuse.(2) do not resterilize.(3) 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.] (4) 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.] 2.Applicable patients (1) patients who are or have been allergic to natural rubber latex (2) patients with known allergy to silver coated catheter.Intended use & effect- efficacy] the device combines an indwelling bladder catheter and a urinary drainage bag that are used for urinary drainage and bladder irrigation.[directions for use] 1.Method of use the device is intended for single use only and is not reusable.(1) to secure a sterile field for the procedure, spread a clean wrapping paper.(2) place waterproof sheet beneath patient¿s buttocks.(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 the distal end of the catheter with water-soluble lubricant packaged in the tray.(6) insert catheter into the urethral meatus, and advance it until the balloon enters the bladder and urine flows out through the catheter.Using a syringe packaged in the tray, infuse the specified volume of sterile water into the inflation lumen to inflate the balloon.(7) pull catheter to seat the balloon at the level of the bladder neck and secure placement.(8) keep the drainage bag below the bladder level without touching the floor.(9) secure drainage tube to bed sheet with clip to ensure that there is neither twist nor kink in the tube.(10) to deflate balloon and remove catheter, insert a luer tip (needleless) syringe in the inflation valve to allow the water drain spontaneously.After balloon deflation, withdraw the catheter while confirming that no resistance is encountered. 1) occlude drainage tubing a minimum of 10 cm below the sampling port by kinking the tubing until urine fills the tubing up to near (slightly above) the sampling port.2) swab surface of site with antiseptic wipe.3) using aseptic technique, position the needle-less syringe (slip-tip type or luer-lock type) in the center of the sampling port.The syringe should be held perpendicular to the surface of the sampling port.Press the syringe and twist to lock the syringe onto the sampling port.4) aspirate desired volume of urine.After sampling, detach the syringe.Ensure that the rubber stem of the sampling port has returned to its original position.5) unkink tubing. catheter is pre-connected to ez-lok ®, and the connecting part is covered with red seal (tamper-evident seal).Remove the seal by grasping the tab at the end of the seal and pulling along perforations, and then disconnect the catheter and the tubing using aseptic technique.2.Precautions for use (1) when resistance is encountered in inserting catheter, stop the procedure and remove the catheter.(2) when deflating balloon, do not aspirate with a syringe.[the inflation lumen for balloon deflation may be occluded by negative pressure, and as a result the catheter cannot be removed.] (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.] (4) do not wipe catheter surface with organic solvents such as alcohol.(5) do not aspirate urine through drainage funnel wall.(6) since movement of the body, etc.May twist or bend catheter to cause occlusion, care should be taken to fix the catheter securely.(7) when urinary flow cannot be noted, confirm that the catheter is neither occluded nor broken.(8) avoid force on the connecting parts as they may be accidentally disconnected due to the weight of the drainage bag etc.And may cause urine spill.(9) do not pull or twist the outlet tube.Also, do not squeeze the drainage bag.[the joint of the drainage bag and the outlet tube may be damaged and urine leakage may occur.] (10) when disposing of urine, observe the following; 1) remove the outlet tube from the housing of the urine drainage bag.2) lift the green lever to open with holding the outlet tube.Be careful not to pull the outlet tube when lifting the green lever.3) when disposal of urine is completed, close the green lever and put the outlet tube into the housing.[precautions] 1.Precautions for use (exercise caution when using the device in the following patients) (1) 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 (1) when catheter is inadvertently removed, inspect the balloon and shaft of catheter for rupture, defect, etc.Before inserting a new catheter.(2) when any part of the balloon and/or the catheter is missing, consider removing them using a cystoscope.(3) when it is difficult to remove catheter by deflating the balloon, take appropriate measures according to the section ¿troubleshooting¿. 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.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 may remain in the bladder.Therefore, try non-rupture method first.A.Non-rupture method 1) attach luer tip syringe to the inflation valve.Inject an additional amount of sterile water into the inflation lumen and pump the plunger.2) if situation wouldn't be improved with 1), sever the inflation funnel of valve.3) if situation wouldn¿t be improved with 2), sever the catheter shaft while holding it with forceps so that the distal segment may not be drawn into the urethra 4) if situation wouldn't be improved with 3), insert a needle into the inflation lumen and pump the plunger.5) if situation wouldn't be improved with 4), insert a fine steel wire through the inflation lumen of catheter.B.Balloon-rupture method 1) inject 100-200ml/cc of saline solution warmed to body temperature into the bladder through the drainage lumen, and then inject a large amount of water or 10-15 ml/cc of mineral oil into the balloon through the inflation lumen with a needle to induce rupture.After rupture of the balloon, irrigate the bladder.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, burst the balloon by puncture with a needle from the perineal (or suprapubic) region or through the rectum under ultrasonographic guidance.C) in female patients, burst the balloon by insertion of a needle along the urethra 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 [storage method and expiration date] 1.Storage store in a dry, cool place away from heat, moisture, and direct sunlight.2.Expiration date indicated on the direct package and the outer box.".
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