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 one used silicone catheter.Initial visual inspection noted not obvious defects.Per functional testing; the balloon was inflated with air then deflated and no cuff roll was formed.After that, the was introduced with 10cc of mix of water and blue methylene with a syringe, the catheter was left for 3 minutes resting in a flat surface.Then it deflated by itself and no cuff roll was found.Dimensional testing found the active length was measured with a digital caliper and results found: the catheter active length was found within specification.The reported event was unconfirmed as the product problem could not be reproduced.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instruction for use states 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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