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Catalog Number 175808 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Kidney Infection (4502)
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Event Date 08/10/2023 |
Event Type
Injury
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Manufacturer Narrative
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The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.H11: section a through f - the information provided by bd represents all 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 bd.H3 other text: the device was not returned.
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Event Description
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It was reported that in an online survey, a physician stated that the patient did not experience an adverse event prior to the device placement and that pyelonephritis complications were directly attributable to the device."nil" was needed for pyelonephritis in relation to 175808e¿bard® lubri-sil®, all-silicone, hydrogel-coated, pediatric-length foley catheter with 3 ml balloon for pediatric use, 8 fr.It was unknown what medical intervention was provided.
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Event Description
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It was reported that in an online survey, a physician stated that the patient did not experience an adverse event prior to the device placement and that pyelonephritis complications were directly attributable to the device."nil" was needed for pyelonephritis in relation to 175808e¿bard® lubri-sil®, all-silicone, hydrogel-coated, pediatric-length foley catheter with 3 ml balloon for pediatric use, 8 fr.It was unknown what medical intervention was provided.
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Manufacturer Narrative
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The reported event was inconclusive because no sample was returned.A potential root cause for this failure could be ¿materials of construction are not biocompatible".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 were found adequate and state the following: "warning: do not use ointments or lubricants having a petrolatum base.They will damage silicone.Visually inspect the product for any imperfections or surface deterioration prior to use.Use luer tip syringe to inflate with stated ml of sterile water.Or for pre-filled products, remove clip and squeeze reservoir to inflate with stated ml of sterile water.Storage: store catheters at room temperature away from direct exposure to light, preferably in the original box.For urological use only.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.Allow the pressure within the balloon to force the plunger back and fill the syringe with water.If you notice slow or no deflation, re-seat the syringe gently.Use only gentle aspiration to encourage deflation if needed.Vigorous aspiration may collapse the inflation lumen, preventing balloon deflation.If necessary, 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." h11: section a through f - the information provided by bd represents all 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 bd.H3 other text: the device was not returned.
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Search Alerts/Recalls
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