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| Catalog Number 175814 |
| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problem
Inflammation (1932)
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| Event Date 03/29/2022 |
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Event Type
Injury
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Event Description
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It was reported that the patient had to leave some slack in the foley catheter to go from sitting, to standing and to laying down.It was also stated that the patient was having mobility problems as well as bladder problems, due to a neuromuscular disease.It was also stated that the patient had a 500ml collection bag around the calf, during the day and 2-litre collection bag at night.Sometimes the patient just use the valve and drain when full, however patient had prostatitis at the moment ((b)(4)).It was also stated that sometimes the catheter kinks ((b)(4)) and blocks the drainage that was the joint between the catheter tube and the lumen as happened with the 14-inch.The 14inch was removed last week as it kept blocking with debris and clots as well ((b)(4)).The patient currently had a 16-inch which was flowing much better, however that had now kinked approximately halfway between patient meatus and the catheter lumen ( d175816e ).Once the catheter folds over like that it appeared to develop a memory or weakness at that point, it then kept folding over at the same point as the catheter naturally moves around.Patient had tried different underwear loose fit boxers, trunks, boxer briefs, and briefs and none seem to have made much difference.As per the follow up information received via ibc on 25apr2022, it was stated that every time the 14-inch or 16-inch foley catheter kinked and the flow was completely blocked.This caused pain, bladder spasms and bypassing of the catheter.The patient noticed quite quickly during the day as they started to feel full and overnight the patient woke up with wet pyjamas and bedding before feeling full.This was further complicated as shortly because after the 14-inch foley catheter was put in, it kept blocking with clot and debris.The patient was not sure when the blocking due to kink occurred.The patient made numerous requests for the 14-inch to be changed to 16-inch, but the district nurses refused to do it.The patient was sent to a&e.It was stated that the 16-inch catheter worked brilliantly until it kinked.If the patient wanted to change the size 16-inch catheter with the kink, they had to go to a&e again as it had not been in 12 weeks and was not totally blocked.The patient wanted to make sure that they were not doing anything wrong.The patient had a latex allergy, hence they needed a silicone catheter.The patient was treated for urinary tract infection with 7 days of nitrofuration and was 4 weeks into a 12-week course of ciprofloxacin for prostatitis.It was unknown whether those infections were due to the catheter blocking or just risks of an indwelling catheter.The 14-inch catheter was put into the patient on (b)(6) 2022.On (b)(6) 2022, the 14-inch catheter started being painful and blocking with debris and clots.Also, it started bypassing overnight.On (b)(6) 2022, the user noticed that 14-inch was kinking at the joint with lumen overnight.On (b)(6) 2022, the patient was tested positive for a urinary tract infection and treated with nitrofuration in a 7-day course ((b)(4)).On (b)(6) 2022, the patient was diagnosed with prostatitis and started on a 12-week course of ciprofloxacin.On (b)(6) 2022, 14-inch catheter was changed due to bladder pain, blocking and clearing multiple times during the day and the night.It was stated that blocking and unblocking were caused by a mix of debris, clots and tube kinking.On (b)(6) 2022, 14-inch catheter was finally changed for 16-inch at a&e.The patient was more comfortable and there were no problems until 3 days later.On (b)(6) 2022 and (b)(6) 2022, the patient woke up overnight in pain and the bed was soaked from bypassing.The 16-inch catheter was totally blocked by kink.The user had wrapped 3m transpose waterproof surgical tape around the catheter over the kink.This successfully stopped blocking as long as the user checked the catheter position regularly.There were no problems with pain, clots or debris.It was stated that the patient would be more grateful, if there were any tips on caring for all silicone catheter, if they were differing from a latex or ptfe urethral catheter, indwelling catheter and foley catheter.The patient was familiar with indwelling catheters as they had needed them on and off for the past 30 years.The patient would prefer intermittent self-catheterization, but for the medical reasons, this was not always practical or possible.No medical intervention was reported for pain and bladder spasms.
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Manufacturer Narrative
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The reported event was inconclusive because no sample was returned.A potential root cause for this failure could be ¿manufacturing related due to operator error/ mechanical error/ thin rubberized layer".The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: 'warnings: method for use: do not inflate the balloon in the urethra.[the urethra may be injured.] do not pull the catheter hard.[the bladder/urethra may be injured.Applicable patients, patients with delirium who might pull out catheter [when patient tugs at catheter unconsciously, the bladder and urethra may be damaged.] [contraindications] method for use: do not reuse.Do not resterilize.This device contains 10% povidone-iodine.For patients with past history of allergic hypersensitivity to povidone-iodine or iodine, consider using alternative disinfectants.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.] (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.] applicable patients, 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 this product is made with bacti-guard® silver alloy coating.Sizes of catheters: available in sizes 8 to 24 every 2fr.Foley catheter.Accessories: closed drainage bag (the illustration shows one example of typical configurations.) 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 combines a disposable catheter designed to be placed in the bladder, and a urine drainage bag.[directions for use] method of use: the device is intended for single use only and is not reusable.To secure a sterile field for the procedure, spread a clean wrapping paper.Place waterproof sheet beneath patient¿s buttocks.Put on sterile gloves.Open tray and place it on the wrapping paper.Cleanse the area around the external urethral meatus with the cotton balls immersed in the antiseptics.Lubricate the distal end of the catheter with water-soluble lubricant packaged in the tray.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.Pull catheter to seat the balloon at the level of the bladder neck and secure placement.Keep the drainage bag below the bladder level without touching the floor.Secure drainage tube to bed sheet with clip to ensure that there is neither twist nor kink in the tube.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-lok® sampling port: 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.Swab surface of site with antiseptic wipe.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.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.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.Precautions for use when resistance is encountered in inserting catheter, stop the procedure and remove the catheter.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.] 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.] do not wipe catheter surface with organic solvents such as alcohol.Do not aspirate urine through drainage funnel wall.Since movement of the body, etc.May twist or bend catheter to cause occlusion, care should be taken to fix the catheter securely.When urinary flow cannot be noted, confirm that the catheter is neither occluded nor broken.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.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.] when disposing of urine, observe the following; remove the outlet tube from the housing of the urine drainage bag.Lift the green lever to open with holding the outlet tube.Be careful not to pull the outlet tube when lifting the green lever.When disposal of urine is completed, close the green lever and put the outlet tube into the housing.When using statlock® foley, observe the following; 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.Minimize catheter manipulation during statlock® stabilization device application and removal.Do not use the statlock® device for patients showing allergic reaction to tape or adhesive.Conduct skin assessment prior to application and repeat daily per facility protocol.The statlock® device should be assessed daily and changed when clinically, indicated, at least every seven days.After placing the statlock® device, allow to dry completely (10-15 seconds) due to alcohol included in skin protectant.Use alcohol pads when removal.Do not pull or force pad to remove.[precautions] precautions for use (exercise caution when using the device in the following patients) 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.Important precautions when catheter is inadvertently removed, inspect the balloon and shaft of catheter for rupture, defect, etc.Before inserting a new catheter.When any part of the balloon and/or the catheter is missing, consider removing them using a cystoscope.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.Non-rupture method (sterile water is withdrawn without bursting the balloon.) 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 attach luer tip syringe to the inflation valve.Inject an additional amount of sterile water into the inflation lumen and pump the plunger.If situation wouldn't be improved with 1), sever the inflation funnel of valve.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.If situation wouldn't be improved with insert a needle into the inflation lumen and pump the plunger.If situation wouldn't be improved with insert a fine steel wire through the inflation lumen of catheter.Balloon-rupture method: 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.Situation wouldn't be improved with attempt following procedures.Under the radioscopic observation, infuse a contrast medium into the bladder, and burst the balloon by suprapubic puncture of the bladder.In male patients, burst the balloon by puncture with a needle from the perineal (or suprapubic) region or through the rectum under ultrasonographic guidance.In female patients, burst the balloon by insertion of a needle along the urethra.Malfunction and adverse events 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 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] storage- store in a dry, cool place away from heat, moisture, and direct sunlight.Expiration date- indicated on the direct package and the outer box.''.
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Manufacturer Narrative
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The reported event was inconclusive since it was unknown how the products reacted in the particular patient's body.A potential root cause for this failure could be materials of construction are not biocompatible.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: "to defl ate catheter balloon: gently insert a luer slip tip syringe in the catheter valve.Never use more force than is required to make the syringe ¿stick¿ in the valve.Allow the pressure within the balloon to force the plunger back and fi ll the syringe with water.If you notice slow or no defl ation, re-seat the syringe gently.Use only gentle aspiration to encourage defl ation if needed.Vigorous aspiration may collapse the infl ation lumen, preventing balloon defl ation.If necessary, contact adequately trained professional for assistance, as directed by hospital protocol.Should balloon rupture occur, care should be taken to assure that all balloon fragments have been removed from the patient." h11: section a through f - the information provided by bard 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 bard.H3 other text: the actual/suspected device was inspected.
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Event Description
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It was reported that the patient had to leave some slack in the foley catheter to go from sitting, to standing and to laying down.It was also stated that the patient was having mobility problems as well as bladder problems, due to a neuromuscular disease.It was also stated that the patient had a 500ml collection bag around the calf, during the day and 2-litre collection bag at night.Sometimes the patient just use the valve and drain when full, however patient had prostatitis at the moment ( d175816e).It was also stated that sometimes the catheter kinks ( d175814e ) and blocks the drainage that was the joint between the catheter tube and the lumen as happened with the 14-inch.The 14inch was removed last week as it kept blocking with debris and clots as well ( d175814e ).The patient currently had a 16-inch which was flowing much better, however that had now kinked approximately halfway between patient meatus and the catheter lumen ( d175816e ).Once the catheter folds over like that it appeared to develop a memory or weakness at that point, it then kept folding over at the same point as the catheter naturally moves around.Patient had tried different underwear loose fit boxers, trunks, boxer briefs, and briefs and none seem to have made much difference.As per the follow up information received via ibc on 25apr2022, it was stated that every time the 14-inch or 16-inch foley catheter kinked and the flow was completely blocked.This caused pain, bladder spasms and bypassing of the catheter.The patient noticed quite quickly during the day as they started to feel full and overnight the patient woke up with wet pyjamas and bedding before feeling full.This was further complicated as shortly because after the 14-inch foley catheter was put in, it kept blocking with clot and debris.The patient was not sure when the blocking due to kink occurred.The patient made numerous requests for the 14-inch to be changed to 16-inch, but the district nurses refused to do it.The patient was sent to a&e.It was stated that the 16-inch catheter worked brilliantly until it kinked.If the patient wanted to change the size 16-inch catheter with the kink, they had to go to a&e again as it had not been in 12 weeks and was not totally blocked.The patient wanted to make sure that they were not doing anything wrong.The patient had a latex allergy, hence they needed a silicone catheter.The patient was treated for urinary tract infection with 7 days of nitrofuration and was 4 weeks into a 12-week course of ciprofloxacin for prostatitis.It was unknown whether those infections were due to the catheter blocking or just risks of an indwelling catheter.The 14-inch catheter was put into the patient on (b)(6) 2022.On (b)(6) 2022, the 14-inch catheter started being painful and blocking with debris and clots.Also, it started bypassing overnight.On (b)(6) 2022, the user noticed that 14-inch was kinking at the joint with lumen overnight.On (b)(6) 2022, the patient was tested positive for a urinary tract infection and treated with nitrofuration in a 7-day course (d175814e ).On (b)(6) 2022, the patient was diagnosed with prostatitis and started on a 12-week course of ciprofloxacin.On 06apr2022, 14-inch catheter was changed due to bladder pain, blocking and clearing multiple times during the day and the night.It was stated that blocking and unblocking were caused by a mix of debris, clots and tube kinking.On (b)(6) 2022, 14-inch catheter was finally changed for 16-inch at a&e.The patient was more comfortable and there were no problems until 3 days later.On (b)(6) 2022 and (b)(6) 2022, the patient woke up overnight in pain and the bed was soaked from bypassing.The 16-inch catheter was totally blocked by kink.The user had wrapped 3m transpose waterproof surgical tape around the catheter over the kink.This successfully stopped blocking as long as the user checked the catheter position regularly.There were no problems with pain, clots or debris.It was stated that the patient would be more grateful, if there were any tips on caring for all silicone catheter, if they were differing from a latex or ptfe urethral catheter, indwelling catheter and foley catheter.The patient was familiar with indwelling catheters as they had needed them on and off for the past 30 years.The patient would prefer intermittent self-catheterization, but for the medical reasons, this was not always practical or possible.No medical intervention was reported for pain and bladder spasms.
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