| Catalog Number |
0165SI18 |
| Medical Device Problem Code |
Difficult to Remove (1528)
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| Health Effect - Clinical Code |
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
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| Date of Event |
04/30/2025
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Type of Reportable Event
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Serious Injury
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Event or Problem Description
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It was reported that on (b)(6) 2025, the foley catheter was placed.On (b)(6) 2025, the balloon fixation made it difficult to drain the water, making the removal difficult.This was a report on the procedure carried out at the nearby (b)(6) hospital after the balloon was placed at (b)(6) hospital and the water could not be removed upon removal.As per additional information received on 09may2025, the balloon puff was partially raised on the ultrasound and could not be deflated even after cuff washing.Percutaneous puncture was also attempted but was difficult, and it was finally removed after several washes.When the cuff was cut and checked, it appeared that the lumen of the cuff had detached, and the false lumen side had stopped contracting.The alternative catheter placement itself was performed without any problems.An 18fr silicone balloon was placed, and although there was mild hematuria, the hospital believes that this was not clinically significant.Antibiotics will be administered for a few days.
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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.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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Additional Manufacturer Narrative
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The reported event was inconclusive because of poor sample condition.It was unknown whether the device had met relevant specifications.Sample has been evaluated and observed catheter was cut at the distal part.Water was able to pass through the lumen when injected with lab syringe and observed no any blockage in the catheter.There was salt was observed inside drainage lumen.However, further functional testing and full investigation could not be performed due to poor sample condition.Unable to determine the deflation time of the used sample due to poor sample condition.Sample was dissected and observed salt accumulation inside lumen that lead to the non-deflation issue.The potential root cause for this failure could be user related (example: over aspirated, incorrect syringe/collapse lumen/sac close eye/valve damage).A review of the device history record did not show any problems or condition that would have contributed to the reported issue.The instructions for use were found adequate and states 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 shape, configuration and principles bard i.C.Silver 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, tweezers, waterproof sheet, gauze pads, cotton balls, vinyl 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.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) secure drainage tube to bed sheet with clip to ensure that there is neither twist nor kink in the tube.(fig.7) 10) 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) 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) 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 does 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) 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.(10) when disposing of urine, observe the 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.11) 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, h.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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Event or Problem Description
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It was reported that on (b)(6) 2025, the foley catheter was placed.On (b)(6) 2025, the balloon fixation made it difficult to drain the water, making the removal difficult.This was a report on the procedure carried out at the nearby (b)(6) hospital after the balloon was placed at (b)(6) hospital and the water could not be removed upon removal.As per additional information received on 09may2025, the balloon puff was partially raised on the ultrasound and could not be deflated even after cuff washing.Percutaneous puncture was also attempted but was difficult, and it was finally removed after several washes.When the cuff was cut and checked, it appeared that the lumen of the cuff had detached, and the false lumen side had stopped contracting.The alternative catheter placement itself was performed without any problems.An 18fr silicone balloon was placed, and although there was mild hematuria, the hospital believes that this was not clinically significant.Antibiotics will be administered for a few days.
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Event or Problem Description
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It was reported that on (b)(6) 2025, the foley catheter was placed.On (b)(6) 2025, the balloon fixation made it difficult to drain the water, making the removal difficult.This was a report on the procedure carried out at the nearby (b)(6) hospital after the balloon was placed at (b)(6) hospital and the water could not be removed upon removal.As per additional information received on 09may2025, the balloon puff was partially raised on the ultrasound and could not be deflated even after cuff washing.Percutaneous puncture was also attempted but was difficult, and it was finally removed after several washes.When the cuff was cut and checked, it appeared that the lumen of the cuff had detached, and the false lumen side had stopped contracting.The alternative catheter placement itself was performed without any problems.An 18fr silicone balloon was placed, and although there was mild hematuria, the hospital believes that this was not clinically significant.Antibiotics will be administered for a few days.
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Additional Manufacturer Narrative
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The reported event was inconclusive because of poor sample condition.It is unknown whether the device had met relevant specifications.Sample has been evaluated and observed catheter was cut at the balloon area.Water was able to pass through the inflation lumen when injected with lab syringe and observed no any blockage in the inflation lumen of catheter.Dissected the catheter and observed salt deposits along the drainage lumen wall.Based on the sample condition observed at cut area, there was a visible gap between the catheter shaft and the balloon sac, and the balloon did not fully contract.However, unable to determine what elements existed during the placement and use of the catheter that may have led to this condition.The potential root cause for this failure could be user related (example: over aspirated, incorrect syringe/collapse lumen/sac close eye/valve damage).Pfmea ra87p002 rev 18 (rubberize dipping process) was reviewed for this investigation.The failure mode is addressed in step/item # 4.A potential root cause for this failure mode could be, thin rubberize wall that causing collapse/pinch inflation lumen under the balloon or along the shaft.Based on information in the pfmea, the risk of this failure is medium.Current controls in place are adequate to mitigate this failure mode.A review of the device labeling have been conducted for investigation purposed.The ifu is attached in the investigation overview element.A review of the device history record did not show any problems or condition that would have contributed to the reported issue.Therefore no additional action required at this time.Correction: e, h.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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