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The reported event was inconclusive because of poor sample condition.It is unknown whether the device had met relevant specifications.It was unknown whether the product had caused the reported failure.Sample has been evaluated and observed catheter was cut into 3 pieces.Water was able to pass through the lumen when injected with needle syringe and observed no any blockage in the catheter.However, further functional testing and full investigation could not be performed due to poor sample condition.The potential root cause for this failure could be user related (example: over aspirated, incorrect syringe/collapse lumen/sac close eye/valve damage).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 may be injured.] 2.Applicable patients (1)patientswith delirium who might pull out catheter [when patient tugs at catheter unconsciously, the bladder and urethra may be damaged.] [contraindications] 1.Method for use: (1) do not reuse.(2) do not resterilize.(3) this device contains 10% povidone-iodine.For patients with past history of allergic hypersensitivity to povidone-iodine or iodine, consider using alternative disinfectants.(4) be careful that the catheter is not exposed to ointments, contrast medium or oil-based lubricants (including vegetable oils such asolive oil, mineral oils such as white petrolatum and animal oils).[they may damage the device and may burst balloon.] (5) do not hold the device with forceps, etc.Avoid contact with any blades or sharp-edged instruments.[catheter damage may cause balloonrupture and accidentalballoon removal or failure to deflate or remove the balloon.] 2.Applicable patients (1)do not use in patients who are or have been allergic to natural rubberlatex [shape, configuration and principles] bard®i.C.Foley tray b consists of a balloon catheter, urine-collecting bag for closed drainage system, syringe prefilled with sterile water, water-soluble lubricant, antiseptic solution, waterproof sheet, tweezers, gauze pads, cotton balls, vinyl glovesand statlock foley.There are two types of catheter, two way and three way, and several types of closed drainage bags.The catheter and/or bag included in the tray will depend on the product.Also, the statlock foley included in the tray will depend on the product.Material: balloon catheter: natural rubber latex.Sizes of catheters: 2.Available in sizes 8 to 24 every 2fr: 1.Foley catheter: shaft; 2.Accessories: closed drainage bag; (the illustration shows one example of typical configurations.) clip; lever (green); housing; bard ez-lok sampling port; drainage tube; outlet tube; syringe prefilledwith sterile water; water soluble lubricant; antiseptics: bard®10% povidone-iodine solution; tweezers; gauze pads; waterproof sheet; cotton balls; gloves; statlock foley; [intended use & effect-efficacy]3.The device combines an indwelling bladder catheter and aurinary 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 sterilefield for the procedure, spread a clean wrapping paper.(2) place waterproof sheet beneath patient¿s buttocks.(fig.1) (3) put on sterile gloves.Open tray and place it on the wrapping paper.(fig.2) fig.1 fig.2 (4) cleanse the area around the external urethral meatus with the cotton balls immersedin the antiseptics.(fig.3) (5) lubricate the distal end of the catheterwith water-soluble lubricant packaged in the tray.(fig.4) fig.3 fig.4 (6) insert catheter into the urethral meatus, and advance it until the balloon enters the bladderand 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.(fig.5) fig.5 (7) pull catheter to seat the balloon at the level of the bladder neckand secure placement.(8) keep the drainage bag below the bladder level without touching the floor.(fig.6) (9) securedrainagetubeto bed sheet with clip to ensure that there isneither twist nor 4 kink in the tube.(fig.7) fig.6 fig.7 (10) to deflate balloon and remove catheter, inserta luertip(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 fillsthe tubing up to near (slightly above) the sampling port.2) swab surface of site with antiseptic wipe.3) using aseptictechnique, position theneedle-lesssyringe (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 thesyringe and twist to lock the syringe onto the sampling port.(fig.8) fig.8 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 partiscovered with red seal (tamper-evident seal).Remove the seal by grasping the tab at the end of the seal and pullingalong perforations, and then disconnect the catheter and the tubing using aseptic technique.(fig.9) fig.9 2.Precautions for use (1)when resistance is encountered in inserting catheter, stop the procedure and 5 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 cathetercannot 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)using 3way catheter, capped adapter attached to irrigation lumen is designed to connect catheter with bladder irrigation line or tube.While in use, open the cap and attach irrigation line or tube to itusing aseptic technique.After use, cleanse the opening of the lumen and close the cap.(10) do not pull or twist the outlettube.Also, do not squeezethe drainagebag.[the jointofthe drainagebag and the outlet tube maybe damaged and urine leakage may occur.] (11) when disposing of urine, observe the following; 1) remove the outlet tubefrom the housing of the urine drainagebag.2) liftthe green lever to open with holding the outlettube.Be careful not to pull the outlet tube when lifting the green lever.3) when disposal of urine was completed, close the green lever and put the outlet tube into the housing.(12)when using statlock foley, observe the following; 1)do not use the statlock device where loss of adherence could occur, such as with a confused patient, unattended access device, diaphoretic or nonadherent skin.2) minimize catheter manipulationduring statlock stabilization device application and removal.3)do not use the statlock device for patients showing allergic reaction to tape or adhesive.4)conduct skin assessment prior to application and repeat daily per facility protocol.5)the statlock device should be assessed daily and changed when clinically, indicated, at least every seven days.6)after placing the statlock device, allow to dry completely (10-15 seconds) due toalcoholincluded in skin protectant.7) use alcoholpadswhen removal.Do not pull or force pad to remove.[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 6 for rupture, defect, etc.Before inserting a new catheter.(2)when any part oftheballoon and/or the catheteris 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 mayremain in the bladder.Therefore, try non-rupture method first.A.Non-rupture method 1)attach luer tip syringe to the inflationvalve.Inject an additional amount of sterile water into the inflation lumen and pump the plunger.2)if situationwouldn't be improved with 1), sever the inflation funnel of valve.(fig.10) fig.10 3)if situation wouldn¿t be improved with 2), sever the catheter shaft while holding it with forceps so thatthe distal segment may not be drawn into the urethra.(fig.11) fig.11 4)if situation wouldn't be improved with3), insert a needle into the inflation lumen and pump the plunger.(fig.12) fig.12 5)if situation wouldn't be improved with 4), insert a fine steel wire through the inflation lumen of catheter.(fig.13)7 fig.13 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 ofwater 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.14) mineral oil fig.14 2)if situation wouldn't beimproved 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.15) fig.15 b)in male patients, burst the balloon by puncture with a needle from the perineal(or suprapubic) region or through the rectumunder ultrasonographic guidance.(fig.16) fig.16 c)in female patients, burst the balloon by insertion of a needle along the urethra.(fig.17) fig.178 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." corrections: d 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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