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 catheter.Per visual evaluation, no damages along the catheter were found.Per the functional evaluation, the balloon was inflated with 10 cc of air using a syringe and was then deflated.After the balloon was inflated with 10 cc of a mix of tap water and blue methylene using a syringe, a leak was immediately observed due to a balloon pinhole.The sample was observed under 10 x magnification and no embedded particles were found in the balloon area.Per the dimensional evaluation, the balloon's active length measured 0.8380¿ on one side and 0.8358¿ on the other side (specification is (b)(4)).The balloon active length was found to be within specifications.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: "recommended inflation capacities 3 cc balloon: use 5 ml sterile water.5 cc balloon: use 10 ml sterile water 30 cc balloon: use 35 ml sterile water do not exceed recommended capacities.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 deterioration prior to use.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." 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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