It was reported that survey respondent mentioned about symptomatic urinary tract infection, pain, hematuria, catheter blockage, leakage and retained fragments from catheter when they were asked of complications while using the lubrisil hydrogel coated silicone foley catheter (d1758(12-24e)).It was unknown what medical intervention was provided.
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The reported event was inconclusive because no sample was returned.It is unknown whether the device had met relevant specifications.The product was used for treatment purposes.It was unknown whether the product had caused the reported failure.A potential root cause for this failure could be ¿lumen wall thickness undersized/ inadequate material selection".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: "bard® urological catheter warning: do not use ointments or lubricants having a petrolatum base.They will damage silicone.Warning: after use, this product may be a potential biohazard.Handle and dispose of in accordance with accepted medical practice and applicable laws and regulations.This is a single use device.Do not resterilize any portion of this device.Reuse and/or repackaging may create a risk of patient or user infection, compromise the structural integrity and/or essential material and design characteristics of the device, which may lead to device failure, and/or lead to injury, illness or death of the patient.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.For urological use only.Do not use if package is damaged.Single use only.Do not resterilize this is a single use device.Do not resterilize any portion of this device.Reuse and/or repackaging may create a risk of patient or user infection, compromise the structural integrity and/or essential material and design characteristics of the device, which may lead to device failure, and/or lead to injury, illness or death of the patient.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.Female use only syringe of sterile water for balloon inflation refer to direct unit label for product content and gender specific use where applicable.Caution, consult accompanying documents.Storage: store catheters at room temperature away from direct exposure" correction: g h11: section a through f - the information provided by bd 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 bd.H3 other text : the device was not returned.
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It was reported that survey respondent mentioned about symptomatic urinary tract infection, pain, hematuria, catheter blockage, leakage and retained fragments from catheter when they were asked of complications while using the lubrisil hydrogel coated silicone foley catheter (d1758(12-24e)).It was unknown what medical intervention was provided.
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