It was reported that the survey respondent stated the bardex 3-way ptfe coated latex foley catheter, 30 ml balloon, did not perform as intended and elaborated as hematuria not clearing as much when asked if the foley catheter performed as intended and resulted in the clinical outcome of successful urinary drainage from the bladder or from the nephrostomy placement.
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The reported event was inconclusive because no sample was returned.A potential root cause for this failure could be ¿walls do not have enough hoop strength¿.It was 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.The lot number was 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 latex.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.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.Do not resterilize single use only.Do not reuse.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.Consult instructions for use.Do not use if package is damaged.Warning: after use, this product may be a potential biohazard.Handle and dispose of in accordance with accepted medical practice and applicable laws and regulation.¿ correction: e.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.
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It was reported that the survey respondent stated the bardex 3-way ptfe coated latex foley catheter, 30 ml balloon, did not perform as intended and elaborated as hematuria not clearing as much when asked if the foley catheter performed as intended and resulted in the clinical outcome of successful urinary drainage from the bladder or from the nephrostomy placement.
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