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 : the device was not returned.
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The reported event was inconclusive because no sample was returned.A potential root cause for this failure could be obstruction in tube, kinked tubing".It was unknown whether the device had met relevant specifications.A review of the device history record did not show any problems or conditions that would have contributed to the reported issue.The instructions for use were found adequate and states the following: warning: do not use ointments or lubricants having a petrolatum base.They will damage the catheter.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.For pre-filled products, remove clip and squeeze reservoir to inflate with stated ml of sterile water.For urological use only.Bard, bardia, bardex, uriplan, ez-lok, and lubricath are trademarks and/or registered trademarks of c.R.Bard, inc.Manufacturer: 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.Valve type: use luer slip tip syringe.Do not use needle.Recommended inflation capacities 3cc balloon: use 5ml sterile water 5cc balloon: use 10ml sterile water 15cc balloon: use 20ml sterile water 20cc balloon: use 25ml sterile water 30cc balloon: use 35ml sterile water 40cc balloon: use 45ml sterile water 75cc balloon: use 80ml sterile water do not exceed recommended capacities.A new connector with a needle free sample port has been added to this product.Instructions for use for the needle-free sampling: kink the drainage tubing at a minimum of 5cm below the sampling port.Wipe the surface of the port with an alcohol swab.Using an aseptic technique, position the syringe (luer slip tip only) in the centre, perpendicular to the surface of the port, and then press the tip of the syringe into the sampling port.Aspirate the desired volume and then remove the syringe.Wipe the surface of the port with an alcohol swab.Unkink the tubing and send the correctly labelled specimen to the laboratory.Units this is a single use device.Do not re-sterilize 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.Do not use if package is damaged single use do not re-sterilize contains or presence of natural rubber latex.Caution: this product contains natural rubber latex which may cause allergic reactions.Keep away from sunlight 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.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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