PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590 BARDEX 2-WAY 5CC ALL-SILICONE FOLEY CATHETER, TWO OPPOSED EYES
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Catalog Number 165816 |
Device Problem
Material Integrity Problem (2978)
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Patient Problems
Calcium Deposits/Calcification (1758); Hemorrhage/Bleeding (1888); Scar Tissue (2060)
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Event Date 12/11/2013 |
Event Type
Injury
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Manufacturer Narrative
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The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.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.The device was not returned.
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Event Description
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It was reported that the catheter allegedly, had a hard edge on the end of it.Upon removal of the catheter, the patient allegedly, immediately experienced bleeding upon urination and damage to delicate urethral tissue and compromised urine flow.The torn tissue healed with scar tissue which became a stricture or narrowing of the urethral opening causing a moderate bulbous urethral stricture, that lead to urinary retention which resulted in calcifications in the bladder, a urinary tract infection; requiring antibiotics for treatment, and bladder damage to include bladder stones, which allegedly required bladder surgery and the need for multiple urethral dilations.As a result of the reported ailments, the patient was unable to empty their bladder and allegedly had to alternatively use an intermittent straight catheterization device.
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Manufacturer Narrative
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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 states the following: "recommended inflation capacities: 3cc balloon: use 5ml sterile water, 5cc balloon: use 10ml sterile water, 30cc balloon: use 35ml sterile water, do not exceed recommended capacities.To deflate catheter balloon: gently insert a syringe in the catheter valve.Never use more force than is required to make the syringe ¿stick¿ in the valve.If you notice slow or no deflation, re-seat the syringe gently.Allow the balloon to deflate slowly on its own.Do not aspirate or manually accelerate the deflation of the balloon.If permitted by hospital protocol, the valve arm may be severed.If this fails, contact adequately trained professional for assistance, as directed by hospital protocol.Visually inspect the product for any imperfections or surface deterioration prior to use." (b)(4).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.The device was not returned.
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Event Description
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It was reported that the catheter allegedly, had a hard edge on the end of it.Upon removal of the catheter, the patient allegedly, immediately experienced bleeding upon urination and damage to delicate urethral tissue and compromised urine flow.The torn tissue healed with scar tissue which became a stricture or narrowing of the urethral opening causing a moderate bulbous urethral stricture, that lead to urinary retention which resulted in calcifications in the bladder, a urinary tract infection; requiring antibiotics for treatment, and bladder damage to include bladder stones, which allegedly required bladder surgery and the need for multiple urethral dilations.As a result of the reported ailments, the patient was unable to empty their bladder and allegedly had to alternatively use an intermittent straight catheterization device.
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