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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Received 1 used silicone foley catheter only.The reported event was confirmed as cause unknown.Per visual evaluation, cuff roll not was observed.No other defects were observed.Per 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 in a flat surface.Then it was deflated by itself and a cuff roll was formed.Per dimensional evaluation, the active length was measured and results are as follows: short side= 0.3790¿, long side=0.3890¿ (per dwg8070 the active length is 0.3¿ to 0.5¿).The catheter active length was found within specification.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use states the following: ¿to deflate 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.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.Should balloon rupture occur, care should be taken to assure that all balloon fragments have been removed from the patient.Visually inspect the product for any imperfections or surface" (b)(4).
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