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 Problems
Improper or Incorrect Procedure or Method (2017); Device Operates Differently Than Expected (2913)
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Patient Problem
Pain (1994)
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Event Type
Injury
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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 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.The device was not returned.
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Event Description
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It was reported that the balloon had been filled with 10 cc, which was drained gradually with one syringe, and approximately 9 cc drained.Subsequently, there was an attempt to remove the catheter; however, the attempt was unsuccessful.Another syringe was attached; however, no water would drain.It was also reported that lubricant was applied to the insertion site before attempting to remove the catheter.The urologist was called in, and reportedly "yanked" the catheter out which allegedly resulted in pain, trauma to the penis, and self-limited bleeding.After the catheter was removed and inspected, a ridge was found.
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