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The reported event was inconclusive because no sample was available for evaluation and further investigation did not result in any additional findings.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 ¿inadequate valve design".However, there was insufficient information to confirm this potential root cause.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: patients with 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 percentage povidoneiodine.For patients with past history of allergic hypersensitivity to povidoneiodine or iodine, consider using alternative disinfectants.4 be careful that the catheter is not exposed to ointments, contrast medium or oilbased 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.5 do not hold the device with forceps, etc.Avoid contact with any blades or sharpedged instruments.Catheter damage may cause balloon rupture and accidental balloon removal or failure to deflate or remove the balloon.2.Applicable patients: patients with known allergy to silver coated catheter.Shape, configuration and principles.Bardia biocath foley catheter is a balloon catheter.There are different type variations, for example, 2way and 3way products.Some may include a syringe prefilled with sterile water and a water-soluble lubricant as an accessory.Material: balloon catheter: natural rubber latex.This product is made with bactiguard silver alloy coating.Sizes of catheters: available in sizes 12 to 26 every 2fr.1.Balloon catheter.2.Accessories syringe prefilled with sterile water water-soluble lubricant (neither of them may be included in some product variations.) intended use and effect efficacy: this device is designed to be placed in the bladder for the purpose of 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) cleanse the area around the external urethral meatus with the cotton balls immersed in the antiseptics.(2) lubricate the distal end of the catheter with water-soluble lubricant.(3) insert catheter into the urethral meatus and advance it until the balloon enters the bladder and urine flows out through the catheter.Using a needle-less syringe, infuse the specified volume of sterile water into the inflation lumen to inflate the balloon.(4) pull catheter to seat the balloon at the level of the bladder neck and secure placement.(5) to deflate balloon and remove catheter, insert a luer tip (needleless) syringe in the inflation valve to allow the water to drain spontaneously.After balloon deflation, withdraw the catheter while confirming that no resistance is encountered.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) 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.(4) no substance except sterile water should be used to inflate the balloon.(5) do not wipe catheter surface with organic solvents such as alcohol.(6) do not aspirate urine through drainage funnel wall.(7) since movement of the body, etc.May twist or bend catheter to cause occlusion, care should be taken to fix the catheter securely.(8) when urinary flow cannot be noted, confirm that the catheter is neither occluded nor broken.(9) when irrigating, open the cap of irrigation funnel and attach irrigation line or tube under aseptic technique.After use, close the cap.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.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.Balloonrupture method.With balloonrupture method, fragments of the ruptured balloon may remain in the bladder.Therefore, try nonrupture method first.A.Nonrupture 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.Fig.10 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.Fig.11 4 if situation wouldn't be improved with 3, insert a needle into the inflation lumen and pump the plunger.Fig.12 5 if situation wouldn't be improved with 4, insert a fine steel wire through the inflation lumen of catheter.Fig.13 b.Balloonrupture method: 1 inject 100200ml/cc of saline solution warmed to body temperature into the bladder through the drainage lumen, and then inject a large amount of water into the balloon through the inflation lumen with a needle to induce rupture.After rupture of the balloon, irrigate the bladder.Fig.14.2 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.15.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.16 c in female patients, burst the balloon by insertion of a needle along the urethra.Fig.17 mri safety.1 nonclinical studies have shown that temperature sensing catheter is mr conditional.Mr examinations can be safely performed on patients wearing this product under the following conditions self certification.Static magnetic field strength: 1.5t,3.0t.Gradient of static magnetic field: 4,000gauss/cm or less.Wholebody maximum sar specific absorption rate mode indicated by the mr system:2w/kg normal operating mode.The maximum temperature rise that can occur in this product during a scan time of 15 minutes or less per pulse sequence under the above conditions is 1.7 degree celsius or less.The artifact that can occur when the product is imaged using the gradient magnetic field echo method in a 3.0t mr system is 10mm from the actual image of the product.Do not perform scan longer than 60 minutes under the above conditions.2 the position of the wire of the foley catheter with temperature sensor has an effect on the amount of heating that may develop during an mri procedure.Accordingly, the foley catheter with temperature sensor must be positioned in a straight configuration down the center of the patient table i.E., down the center of the mr system without any loop to prevent possible excessive heating associated with an mri procedure.3 remove all electrically conductive material i.E.The removable extension cable, etc.From the bore of the mr system that is not required for the procedure prior to the mr examination.4 keep electrically conductive material that must remain in the bore of the mr system from directly contacting the patient by placing insulating material such as foam rubber padding between the conductive material and the patient.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, failure to measure temperature, improper temperature indication.2 adverse events: urinarytract 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." udi format updated with available product information per gudid.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.
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