PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590 BARDEX 2-WAY 5CC ALL-SILICONE FOLEY CATHETER, TWO OPPOSED EYES, SHORT
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Catalog Number 165816 |
Device Problems
Deflation Problem (1149); Physical Resistance (2578); Device Operates Differently Than Expected (2913)
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Patient Problem
Pain (1994)
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Event Date 02/05/2017 |
Event Type
malfunction
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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.
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Event Description
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It was reported that there was an equipment malfunction.The balloon deflated for catheter removal; however, at the entrance of the urethra, resistance was present.Pain relief was required to remove the device.There was a hard ridge noted at the tip of the catheter upon inspection, after removal.There was no reported patient injury.
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Manufacturer Narrative
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Received 1 used silicone catheter only.The visual inspection noted a cuff roll was present.Per the functional evaluation, the balloon was inflated with air and deflated; a cuff roll was not formed.After that, 10cc of a mix of water and blue methylene was introduced with a syringe, and the catheter was left for 3 minutes resting on a flat surface.Then it was deflated by itself and cuff roll was not formed.Per the dimensional evaluation, the active length was measured and the results were as follows: short side= 0.7170¿, long side=0.7250¿ (per specification, the active length is 0.60¿ to 0.90¿).The catheter active length was found within specification.The reported event was confirmed with an unknown cause.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use state the following: "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.
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Event Description
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It was reported that there was an equipment malfunction.The balloon deflated for catheter removal; however, at the entrance of the urethra, resistance was present.Pain relief was required to remove the device.There was a hard ridge noted at the tip of the catheter upon inspection, after removal.There was no reported patient injury.
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Search Alerts/Recalls
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