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It was reported that over an unspecified time period, several patients experienced urine bypassing their catheters.The catheters were reported to work well for the first couple of days, but after that time, they appeared to fail for an unknown reason.Urine no longer flowed into the catheter and attached bag, and it instead came out of the patient and soiled bedding and clothing.When this occurred, the catheter was removed and a new one was inserted: this seemed to solve the problem.No further information was provided about the patients or the affected products.
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The reported event was inconclusive because no sample was returned.A potential root cause for this failure could be due to "seams bust hole or tear".The dhr review could not be performed without a lot number.The instructions for use were found adequate and state the following: ¿directions for use: visually inspect the product for any imperfections or surface deterioration prior to use.If package is opened or if any imperfection or surface deterioration is observed, do not use.1.Open outer white wrapping to prepare sterile field and place underpad beneath patient, plastic side down.2.If patient has a catheter in-situ 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, reseat the syringe gently.Use only gentle aspiration to encourage deflation if needed.Vigorous aspiration may collapse the inflation lumen, preventing balloon deflation.If permitted by local protocol, the valve arm may be severed.If this fails, contact adequately trained professional for assistance, as directed by local protocol.Should balloon rupture occur, care should be taken to assure that all balloon fragments have been removed from the patient.3.Put on gloves, cover patient with fenestrated drape with open exposing location where catheter will be inserted, and place the apron on yourself.4.Using the two (2) syringes, marked ¿for cleansing purposes only¿, dispense the water onto three (3) gauze squares.Prepare the patient by wiping down the catheter insertion site with the saturated gauze squares.Dry patient with the remaining two (2) gauze squares.Note: do not use this syringe to inflate the catheter balloon.5.Prepare the lubricating gel syringe by removing the cap from the syringe tip.6.For easing the insertion of the catheter into the patient dispense the lubricating gel into the urethra (according to local protocol).7.Remove top tray and open plastic pouch (sleeve) surrounding the catheter.8.Proceed with catheterisation according to local protocol.To inflate catheter, simply insert tip of sterile water-filled syringe gently into valve (do not overpenetrate) and depress plunger.Instill entire amount of sterile water ¿ 10 ml.9.Attach statlock® foley stabilisation device to the bifurcation (y-shape) of the foley catheter (statlock® foley stabilisation device can be used for up to 7 days) and apply.(refer to the instructions for use provided with the statlock® pouch for more details).10.Position hanger on bedside rail near the foot of the bed using sheeting clip to secure drainage tube to sheet.11.The urine meter may be emptied in two ways: a.To empty into the bag, grasp the bottom of the meter and lift up.To ensure that the meter empties completely, lifting again is recommended.B.To empty urine meter into receptacle, twist green portion of drain valve to the left.To close, twist green portion of the drain valve to the right.12.To empty bag: a.To remove outlet tube from housing gently squeeze connector arms and pull tube from housing.B.Release clamp and empty bag.C.After emptying, reclamp outlet tube, and slide connector into housing until connector arms engage.Note: if specimen is required, see directions for using urine sample port.Refer to the folded product insert within the procedure pack for more details regarding the use of the urine meter.13.Periodic inspection of this system should be made to ensure that urine is flowing freely.If a standing column of urine is observed, check for correct positioning of bag and then for a physical obstruction.If correct positioning or removal of physical obstruction does not allow free flow, further investigation should be taken in line with local protocol.14.Catheters should be replaced in accordance with local policy.Directions for using bard® ez-lok® sampling port: bard® ez-lok® sampling port accepts a luer-lock or slip tip syringe.1.Kink drainage tubing a minimum of 7.5 cm below the sample port until urine is visible under access site.2.Swab surface of access site with antiseptic wipe.3.Using aseptic technique, position the syringe in the center of the sampling port.The syringe should be held perpendicular to the surface of the sampling port (at approximately 80-100 degree angle).Press the syringe firmly and twist gently to lock the syringe onto the sampling port.Note: improper penetration technique could cause formation of a drop of urine on the surface of the sample port.Periodic observation of the sampling port is recommended.4.Aspirate desired volume of urine.5.Unkink tubing and send specimen to laboratory.Statlock® foley catheter stabilisation device kit uro-prep® tray with: 2 - gloves (not made with natural rubber latex) 1 - apron 1 - fenestrated drape 5 - gauze squares (7.5 cm x 7.5 cm) 1 - underpad 1 - 10 ml syringe, filled with water soluble lubricating gel 1 - 10 ml syringe, filled with sterile water (only for inflating the catheter) 1 - 10 ml syringe, empty (only for deflating the catheter) 2 - 10 ml syringe, filled with sterile water (for cleansing purposes only) inflate with 10 ml sterile water warning: on catheter, do not use ointments or lubricants having a petroleum base.They will damage the catheter and may cause balloon to burst.Please see reverse side for directions for use ¿ after use, this product may be a potential biohazard.Handle and dispose of in accordance with accepted medical practice and applicable laws, regulations, and policies.¿ sterilized using ethylene oxide ¿ sterile unless package is opened or damaged, except for any individually packaged components within the tray which are not labeled as sterile.These components are not terminally sterilized ¿ do not use if package is damaged ¿ single use only ¿ do not resterilise ¿ this is a single use device.Do not resterilise 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.¿ contains or presence of phthalates: di (2-ethylhexyl) phthalate (dehp) is a plasticizer used in some polyvinyl chloride medical devices.Dehp has been shown to produce a range of adverse effects in experimental animals, notably liver toxicity and testicular atrophy.Although the toxic and carcinogenic effects of dehp have been well established in experimental animals, the ability of this compound to produce adverse effects in humans is controversial.There is no evidence that neonates, infants, pregnant and breast feeding women exposed to dehp experience any related adverse effects.However, a lack of evidence of causation between dehp-pvc and any disease or adverse effect does not mean that there are no risks.¿ correction: f,h 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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It was reported that over an unspecified time period, several patients experienced urine bypassing their catheters.The catheters were reported to work well for the first couple of days, but after that time, they appeared to fail for an unknown reason.Urine no longer flowed into the catheter and attached bag, and it instead came out of the patient and soiled bedding and clothing.When this occurred, the catheter was removed and a new one was inserted: this seemed to solve the problem.No further information was provided about the patients or the affected products.
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