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The reported event was confirmed as manufacturing related.Sample has been evaluated and observed there was tear on both temperature sensing catheter and inflation lumen that occurred water to leak out.The root cause of this failure mode could be "manufacturing related due to operator error/ mechanical error/ thin rubberized layer/poor stripping/shorter rubberize latex dwell".The device history record was reviewed and found a possible manufacturing issue(s) that could have caused or contributed to the reported event.A review of the device labeling have been conducted for investigation purposed."bard® silver tsc tray single use only [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% 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 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 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 [shape, configuration and principles] bard® silver tsc tray consists of a balloon catheter with temperature-sensing, urine-collecting bag for closed drainage system, syringe prefilled with sterile water, water-soluble lubricant, antiseptic solution, tweezers, waterproof sheet, gauze pads, cotton balls ,gloves and statlock® foley.There are several types of closed drainage bags.The bag and statlock® foley included in the tray will depend on the product. balloon catheter: natural rubber latex; silver coating this product is made with bacti-guard® silver alloy coating. available in sizes 14fr, 16fr 1.Balloon catheter with temperature-sensing 2.Accessories closed drainage bag syringe prefilled with 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] the device is a tray kit product that is used for the purpose of urinary drainage and measurement of core body temperature.It combines a balloon catheter with temperature-sensing designed to be placed in the bladder, and a urinary drainage bag.[directions for use] 1.Method of use the device is intended for single use only and is not reusable.2.Precautions for use 1) to secure a sterile field 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) 4) cleanse the area around the external urethral meatus with the cotton balls immersed in the antiseptics.(fig.3) 5) lubricate the distal end of the catheter with water-soluble lubricant packaged in the tray.(fig.4) 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.(fig.5) 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.(fig.6) 9) connect the lead wire of catheter to temperature monitor with extension cable.10) secure drainage tube to bed sheet with clip to ensure that there is neither twist nor kink in the tube.(fig.7) 11) 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.(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 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.(fig.9) 12) when resistance is encountered in inserting catheter, stop the procedure and remove the catheter.13) when deflating balloon, do not aspirate with a syringe by hands.[the inflation lumen for balloon deflation may be occluded by negative pressure, and as a result the catheter cannot be removed.] 14) do not stretch catheter as damage to or dislodgement of lead wire as temperature probe may cause improper temperature measurement.15) when endoelectric surgery is performed, care should be taken to prevent burns in the local tissue.16) do not wet the lead wire and the junction with extension cable.17) this device is compatible only with monitors requiring ysi 400-series type temperature probes.18) 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.] 19) do not wipe catheter surface with organic solvents such as alcohol.20) do not aspirate urine through drainage funnel wall.21) since movement of the body, etc.May twist or bend catheter to cause occlusion, care should be taken to fix the catheter securely.22) when urinary flow cannot be noted, confirm that the catheter is neither occluded nor broken.23) 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.24) 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.] 25) 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.26) 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 manipulation during 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 to alcohol included in skin protectant.7) use alcohol pads when 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 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.(fig.10) 4) 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.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.(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) 1) based on non-clinical studies, mri safety for the device is confirmed under the following conditions: - static magnetic field of 3-tesla or less with regard to magnetic field interactions.- spatial gradient magnetic field of 720-gauss/cm or less with regard to magnetic field interactions.- maximum mr system reported whole-body-averaged specific absorption rate (sar) of 3.5-w/kg at 1.5- or 3-w/kg at 3-tesla for 15 minutes of scanning.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) importantly, the mri procedure should be performed using an mr system operating at a static magnetic field strength of 1.5-tesla or 3-tesla only.The safe use of an mr system operating at lower or higher field strength for a patient with a foley catheter with temperature sensor has not been determined.4) if the foley catheter with temperature sensor has a removable extension cable, it should be disconnected prior to the mri procedure.5) remove all electrically conductive material from the bore of the mr system that is not required for the procedure (i.E., unused surface coils, cables, etc.).6) keep electrically conductive material that must remain in the bore of the mr system from directly contacting the patient by placing thermal and/or electrical insulation including air 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 - 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." h11:section a through f - the information provided by bd represents all of 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.The actual/suspected device was inspected.
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