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The reported event was confirmed and cause unknown.1 sample was confirmed to exhibit the reported failure.The reported failure is considered out of specification.The product was used for treatment.Visual evaluation of the returned sample noted one opened (without original packaging), used two-way silicone foley catheter.Visual inspection of the sample noted balloon burst with no missing pieces.This is out of specification which states, "balloon must not be torn." a potential root cause for this failure could be high modulus silicone.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% 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 patients with known allergy to silver coated catheter.Intended use & effect- efficacy] the device combines a disposable catheter that is designed to be placed in the bladder for the purpose of urinary drainage and a urine drainage bag.[directions for use] 1.Method of use 1) cleanse the area around the external urethral meatus with the packaged cotton balls immersed in the antiseptics.2) lubricate the catheter shaft with the lubricant jelly.3) carefully insert the catheter into the urethral meatus.After the balloon advanced in the bladder, attach the needleless syringe, and gently infuse the specified volume of sterile water to inflate the balloon.4) pull the catheter slightly to seat the balloon at the level of the bladder neck.5) to deflate and remove the balloon, attach a needleless syringe to let sterile water in the balloon come out spontaneously through balloon deflation without aspiration.After balloon deflation, withdraw the catheter slowly while confirming that no abnormal resistance is encountered.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.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) when catheter with temperature-sensing is used, connect lead wire to monitor with relay cable.10) secure drainage tube to bed sheet with clip to ensure that there is neither twist nor kink in the tube.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.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.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) 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.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 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. 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 catheter connector 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.H3 other text : the actual/suspected device was inspected.
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