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 temp-sensing foley catheter.Preliminary visual inspection noted a cuff roll on the balloon.Further visual evaluation a cuff ws not observed.Per functional evaluation the balloon was inflated and deflated by itself and no cuff roll was found.The catheter's length was found within specification.The reported event was confirmed with the case unknown.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 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).
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