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Catalog Number 0165L14 |
Device Problem
Inaccurate Flow Rate (1249)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/23/2021 |
Event Type
malfunction
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Manufacturer Narrative
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The reported event was inconclusive because no sample was returned.It is unknown whether the device had met relevant specifications.The product was used for urological care.It was unknown whether the product had caused the reported failure.Potential root cause for this failure mode could be user related (example: salt accumulation)/block drainage lumen/no drainage eye.The device was not returned for evaluation.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 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 do not use in patients who are or have been allergic to natural rubber latex [intended use & effect- efficacy]: the device combines an indwelling bladder catheter and a urinary drainage bag that are used for urinary drainage and bladder irrigation.[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.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.The device was not returned.
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Event Description
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It was reported that echo confirmed, the foley catheter placement in the bladder, but no urine got flowed.The catheter was replaced, but no urine flowed.After the third replacement, urine was able to flow, but there was a leak.Per follow-up information received via on 08sep2021, no leak issues had been reported in this complaint.
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Event Description
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It was reported that echo confirmed, the foley catheter placement in the bladder, but no urine got flowed.The catheter was replaced, but no urine flowed.After the third replacement, urine was able to flow, but there was a leak.Per follow-up information received via on 08sep2021, no leak issues had been reported in this complaint.
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Manufacturer Narrative
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The reported event was unconfirmed because the reported failure could not be reproduced.The product had not caused the reported failure.No root cause could be found because the reported event was unconfirmed.A review of the device history record did not show any problems or conditions that would have contributed to the reported issue.Therefore, no additional action is required at this time.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 (1) 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) do not use in patients who are or have been allergic to natural rubber latex [intended use & effect- efficacy] the device combines an indwelling bladder catheter and a urinary drainage bag that are used for urinary drainage and bladder irrigation.[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¿.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 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 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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