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The reported event was inconclusive because no sample was returned.However, the potential root cause for this failure mode could be user related (example: contact with sharp object)/ exposure to petrolatum based products/ mechanical failure/ operator error.The labeling and instructions for use were found to be adequate.A review of the device labeling have been conducted for investigation purpose."[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.[ t he bladder/urethra may be injured 2.Applicable patients (1) patients with delirium who might pull out catheter [when patient tugs at catheter unconsciously , the bladder and urethra may be [contraindications] 1.Method f or 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 r emo ve the balloon.] 2.Applicable patients (1) do not use in patients who are or have been allergic to natural rubber latex shape, configuration and principle s b ardex ® b iocath ® foley catheter is a balloon catheter.There are different type variations, fo r example, hematuria types with a catheter internally reinforced with nylon fiber for preventing occlusion of its inner lumen and securing urinary passage.Some may include a water soluble lubricant as an accessory.< material > balloon catheter: natural rubber latex < sizes of catheters > available in sizes 8 to 26 every 2fr 8fr and 10fr : provided with white straightener 2 1.1.Balloon balloon catheter catheter 2way 2way 2way hematuria 2way hematuria 3way 3way in inflation valveflation valve irrigation funnel irrigation funnel drainage funnel drainage funnel inflation funnel inflation funnel balloon balloon drainage lumen drainage lumen irrigat irrigation lumenion lumen inflation lumen inflation lumen cap cap irrigation funnel irrigation funnel inflation valve inflation valve drainage funnel drainage funnel inflation funnel inflation funnel irrigation lumen irrigation lumen balloon balloon drainage lumen drainage lumen inflation lumen inflation lumen 3 3way hematuria 3way hematuria double double--bballalloonoon - - 40 ml balloon is used as a prostatic balloon.40 ml balloon is used as a prostatic balloon.- - 20 ml ba20 ml balloon is used for indwelling in the bladder.Lloon is used for indwelling in the bladder.2.2.Accessories accessories water water--soluble lubricantsoluble lubricant (may not be included in some product variations.)(may not be included in some product variations.) [intended use & effect [intended use & effect-- efficacy]efficacy] the device is des the device is designigned to be placed in the bladder for the purpose of urinary drainage, to be placed in the bladder for the purpose of urinary drainage, bladder irrigation or hemostasis.Bladder irrigation or hemostasis.[ [didirections for userections for use]] 1.1.Method of use method of use the device is intended for single use only and is not reusable.The device is intended for single use only and is not reusable.(1) cleanse the area around the external urethral mecleanse the area around the external urethral meatuatus with the cotton balls immersed with the cotton balls immersed in the antisepticsin the antiseptics.(2) lubricate lubricate the distal end of the the distal end of the catheter with watercatheter with water--soluble lubricant.Oluble lubricant.(3) insert catheter into the urethral meatus and advance it until the balloon enters the insert catheter into the urethral meatus and advance it until the balloon enters the bladder and urine flows out through the cathbladder and urine flows out through the catheteeter.Using a needler.Using a needle--less syringe, infuse less syringe, infuse the specified volume of sterile water into the inflation lumen to ithe specified volume of sterile water into the inflation lumen to inflate the balloon.Nflate the balloon.As as to doubleto double--balloonballoon catheter, infuse through the valve printed bladder for balloon catheter, infuse through the valve printed bladder for balloon inflation.Inflation.After the prostatic balloon partafter the prostatic balloon part ofof the device entethe device enters the prostate, using a rs the prostate, using a needlelessneedleless syringe, infuse the specified volume of sterile water syringe, infuse the specified volume of sterile water through the valve through the valve printed prostate to inflate the balloon.Printed prostate to inflate the balloon.4 ( (4)4) pull catheter to seat the balloon at the level of the bladder neck and secure pull catheter to seat the balloon at the level of the bladder neck and secure placemplacementent.( (5)5) to deflate balloon and remove catheter, insertto deflate balloon and remove catheter, insert a luera luer tiptip (needle(needle--less) syringe in less) syringe in the inflation valthe inflation valve to allow the water ve to allow the water to to drain spontaneously.After balloon deflation, drain spontaneously.After balloon deflation, withdraw the catheter while confirming that no resistance is encountered.Withdraw the catheter while confirming that no resistance is encountered.2 2.Pprecautions for userecautions for use ( (1)1) when resistance is encountered in inserting catheter, stop the procedure and when resistance is encountered in inserting catheter, stop the procedure and removeremove the catheter.The catheter.( (2)2) when deflating balloon, do not aspirate with a syringe.When deflating balloon, do not aspirate with a syringe.[the inflation lumen for [the inflation lumen for balloon deflation may be occluded by negative pballoon deflation may be occluded by negative presressure, and as a result the sure, and as a result the catheter cannot be removed.]catheter cannot be removed.] ( (3)3) when inserting catheter with a stylet, confirm when inserting catheter with a stylet, confirm that the stylet has reached the tip of that the stylet has reached the tip of the catheter, and make sure to keep the stylet in place inside the catheter during the catheter, and make sure to keep the stylet in place inside the catheter during insertion.Insertion.(4) (4) for cathetfor cathetersers with a white straightener, first remove the straightener before with a white straightener, first remove the straightener before lubricating the lubricating the cathetercatheter as inserting theas inserting the catheter with the straightener may cause catheter with the straightener may cause urethralurethral injury.Injury.( (55)) as to doubleas to double--balloon catheter, the valve is labeled balloon catheter, the valve is labeled ¿¿20/40ml/cc20/40ml/cc¿¿; however, infuse ; however, infuse 2525 mmll of sterile water of sterile water into the cap printed bladderinto the cap printed bladder and 45ml into the cap and 45ml into the cap printed printed prostate to inflate the balloprostate to inflate the balloon.On.( (66)) no substance except sterile water should be used to inflate the balloon.No substance except sterile water should be used to inflate the balloon.( (77)) do not wipe catheter surface with organic solvents such as aldo not wipe catheter surface with organic solvents such as alcohcohol.Ol.( (88)) do not aspirate urine through drainage funnel wall.Do not aspirate urine through drainage funnel wall.( (99)) since movement of the body, etc.May twistsince movement of the body, etc.May twist or bend catheter to cause occlusion, or bend catheter to cause occlusion, care should be taken to fix the catheter securely.Care should be taken to fix the catheter securely.( (1010)) when urinary flow cannot be noted, confirm that the cwhen urinary flow cannot be noted, confirm that the cathatheter is neither occluded eter is neither occluded nor broken.Nor broken.(11 (11)) when irrigating, open the cap of when irrigating, open the cap of irrigation funnelirrigation funnel and attach iand attach irrigation line or tube rrigation line or tube ununder aseptic technique.After use, close the cap.Der aseptic technique.After use, close the cap.[precautions] [precautions] 1.1.Precautions for use precautions for use (exercise caution when using (exercise caution when using thethe device in the followidevice in the following ng patientspatients)) ( (1)1) exercise caution when using the device in patients with high urinarexercise caution when using the device in patients with high urinary calcium levels y calcium levels as encrustation on the balloon surface, catheter occlusion or damage may occur.As encrustation on the balloon surface, catheter occlusion or damage may occur.2.Important precautions 2.Important precautions ( (1)1) when catheter is inawhen catheter is inadvedvertently removed, inspect the balloon and shaft of catheter rtently removed, inspect the balloon and shaft of catheter for rupture, defect, etc.Before inserting a nefor rupture, defect, etc.Before inserting a new catheter.W catheter.( (2)2) when when any part ofany part of thethe balloon and/or the catheterballoon and/or the catheter is missingis missing, consider removing , consider removing them using a cystoscope.Them using a cystoscope.( (3)3) when it is difficult towhen it is difficult to reremove catheter by deflating the balloomove catheter by deflating the balloonn, take appropriate , take appropriate measures according to the measures according to the section section ¿¿troubleshootintroubleshootingg¿¿. when it is difficult to remove catheter by deflating the balloon (expressed as when it is difficult to remove catheter by deflating the balloon (expressed as ¿removal¿removal--difficult case¿ hereinafter), take adifficult case¿ hereinafter), take apprppropriate measures according to the following opriate measures according to the following procedures.Procedures.5 the following two methods are available for remova the following two methods are available for removall--difficult cases.Difficult cases.A.Non a.Non--rupture method (sterile water is withdrawn without bursting the balloon.)rupture method (sterile water is withdrawn without bursting the balloon.) b.Balloon b.Balloon--rupture methodrupture method with balloon with balloon--rupture rupture metmethod, fragments of the ruptured balloon hod, fragments of the ruptured balloon maymay remain in the remain in the bladder.Therefore, try nonbladder.Therefore, try non--rupture method first.Rupture method first.A.Non a.Non--rupture methodrupture method 1) 1) attach luer tip syringe to the attach luer tip syringe to the inflationinflation valve.Inject an additional amount of sterile valve.Inject an additional amount of sterile water into the inflation lumen anwater into the inflation lumen and pd pump the plunger.Ump the plunger.2) 2) if situationif situation wouldn't be improved with 1), wouldn't be improved with 1), sever the inflation funnel of valve.(fig.Sever the inflation funnel of valve.(fig.1) 1) fig.1 fig.1 3) 3) if situation wouldnif situation wouldn¿¿t be improved with 2), sever the catheter shaft while holding it t be improved with 2), sever the catheter shaft while holding it with forceps so that the distal segment maywith forceps so that the distal segment may nonot be drawn into the urethra.(fig.2)t be drawn into the urethra.(fig.2) fig.2 fig.2 4) 4) if situation wouldn't be improved withif situation wouldn't be improved with 33), ), insert a neinsert a needle into the inflation lumen and edle into the inflation lumen and pump the pump the plunger.(plunger.(fig.Fig.33)) fig.3 fig.3 5) 5) if situation wouldn't be improved with if situation wouldn't be improved with 44), ), insert a fine steel wire throuinsert a fine steel wire through gh the inflation the inflation lumen of catheter.(lumen of catheter.(fig.Fig.44)) fig.4 fig.4 b.Balloon b.Balloon--rupture methodrupture method 1) 1) inject 100inject 100--200ml/cc of s200ml/cc of saline solution warmed to body temperature into the bladder aline solution warmed to body temperature into the bladder 6 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.(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, burst the balloon by puncture with a needle from the perineal (or suprapubic) region or through the rectum under ultrasonographic guidance.(fig.7) fig.7 c) in female patients, burst the balloon by insertion of a needle along the urethra.(fig.8) fig.8 mineral oil 7 3.3.Malfunction and adverse eventsmalfunction and adverse events (1) (1) malfunctionmalfunction - - catheter kinking, damage, ruptucatheter kinking, damage, rupturere - - difficulty or failure to remove the devicedifficulty or failure to remove the device - - occlusion of catheter inner lumensocclusion of catheter inner lumens - - encrustationencrustation - - accidenaccidental removal of the device due to leakage of sterile water or balloon rupture tal removal of the device due to leakage of sterile water or balloon rupture - - device damage due to inappropriate usedevice damage due to inappropriate use ( (2) adverse events2) adverse events - - urinaryurinary--trtract infectionact infection - - hemorrhage, hematuriahemorrhage, hematuria - - allergy reaction to the deviceallergy reaction to the device - - calculus formation calculus formation - - edemaedema - - paipainn - - discomfortdiscomfort - - injury of bladder or injury of bladder or urethralurethral - - urethritis, urinary incontinenceurethritis, urinary incontinence - - retained balloon fragmentsretained balloon fragments [storage method and expiration date [storage method and expiration date]] 1.Sstoragetorage store in a dry, cool place away from heat, store in a dry, cool place away from heat, moisturemoisture, and direct sunlight, and direct sunlight.2.Expiration dateexpiration date indicate indicated on the direct package and the outer box.D on the direct package and the outer box.[name and address of [name and address of thethe mmaarketing arketing authorizationuthorization holder and manufacturer]holder and manufacturer] licensed marketing approval h licensed marketing approval holdolder: medicon inc.Er: medicon inc.Foreign manufacturer: c.R.Bard, inc.Foreign manufacturer: c.R.Bard, inc.Country of manufacturer: country of manufacturer: usausa contact: contact: 01200120--036036--541(customer service)541(customer service) b baarrdd, bardex , bardex and and biocath biocath are are trademarks and/or trademarks and/or registeregistered trademarks of c.R.Bard, incred trademarks of c.R.Bard, inc.Copyright copyright ©© c.R.Bard, inc.All rights reserved.C.R.Bard, inc.All rights reserved.A dhr review was not required as the lot number was unknown.Therefore, no additional action required at this time." 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 device was not returned.
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