| Catalog Number |
153504 |
| Medical Device Problem Code |
Fluid/Blood Leak (1250)
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| Health Effect - Clinical Code |
No Clinical Signs, Symptoms or Conditions (4582)
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| Date of Event |
06/30/2025
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Type of Reportable Event
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Malfunction
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Additional Manufacturer Narrative
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The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.This report references a us equivalent device.The us udi equivalent for this product number is used.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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Event or Problem Description
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It was reported that it seems that there was leakage after use.The exact location of the urine leakage was unknown.
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Additional Manufacturer Narrative
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The reported event was confirmed ¿ cause unknown.The reported failure was able to be reproduced.The product was used for urological care.Sample has been evaluated and found that there was tear on the backside of drainage bag that allowed urine to leak out.However, the exact cause on how and when problem occurred could not be determined.A potential root cause for this failure could be defective / torn / broken components and might be contributed by user mishandling, potential root cause might be due to bag scratch on the parts of bed.A review of the device history record did not show any problems or conditions that would have contributed to the reported issue.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 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 oi ls 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.Material balloon catheter: natural rubber latex; silver coating this product is made with bacti-guard silver alloy coating.Sizes of catheters 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 percentage 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 patients 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.Direction for use bard ez l ok sampling port 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.How to disconnect catheter from 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 puling 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 ma y 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 ys i 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 join t of the drainage bag and the outlet tube may be damaged and urine leak age 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.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.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.Correction: d, e, h this report references a us equivalent device.The us udi equivalent for this product number is used.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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Event or Problem Description
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It was reported that it seems that there was leakage after use.The exact location of the urine leakage was unknown.Per follow up information received via ibc on 03jul2025, stated that the exact location of the urine leakage was unknown.
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Additional Manufacturer Narrative
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Upon further review, bd has determined that this mdr was reported in error as the reported event was against the drain bag.This report is being submitted as additional information.The reported event was confirmed ¿ cause unknown.The reported failure was able to be reproduced.The product was used for urological care.Sample has been evaluated and found that there was tear on the backside of drainage bag that allowed urine to leak out.However, the exact cause on how and when problem occurred could not be determined.A potential root cause for this failure could be defective / torn / broken components and might be contributed by user mishandling, potential root cause might be due to bag scratch on the parts of bed.A review of the device history record did not show any problems or conditions that would have contributed to the reported issue.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 with delirium who might pull out catheter [when patient tugs at catheter unconsciously the bladder and urethra may be contraindications 1.Method for use: (1) do not reuse.(2) do not resterilize.(3) this device contains 10 percentage 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 oi ls 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 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 patients 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.Direction for use bard ez l ok sampling port 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.How to disconnect catheter from 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 puling 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 ma y 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 ys i 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 join t of the drainage bag and the outlet tube may be damaged and urine leak age 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.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.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 metho d 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.Correction: d, g.This report references a us equivalent device.The us udi equivalent for this product number is used.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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Event or Problem Description
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It was reported that it seems that there was leakage after use.The exact location of the urine leakage was unknown.Per follow up information received via ibc on 03jul2025, stated that the exact location of the urine leakage was unknown.
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Search Alerts/Recalls
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