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It was reported that while removing the patient¿s foley catheter during handover, the user was told that the foley had not been draining during the night and observed 25ml in the urometer.Stated that the catheter tubing was straight to the statlock, no kinks, also the tubing was over the leg just below the knee, no lasso and downward angle to the side at the end of the bed.Customer stated that while walking the patient to the bathroom the customer heard the urine draining into the urometer.Also, the patient sat on the toilet and the customer removed the foley and emptied 325ml.Stated that the foley catheter had not been draining properly.
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The reported event was inconclusive as no sample was returned for evaluation.A potential root cause for this failure could be "tubing design (lumen id undersized)/ lumen wall thickness undersized/ inadequate material selection".It was unknown whether the device had met specifications.The product was used for treatment purposes.It was unknown whether the product had caused the reported failure.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: "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 under pad 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, re-seat the syringe gently.Use only gentle aspiration to encourage deflation if needed.Vigorous aspiration may collapse the inflation lumen, preventing balloon deflation.Wait at least 30 seconds for 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 positioned 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 catheterization according to local protocol.To inflate catheter, simply insert tip of sterile water-filled syringe gently into valve do not over penetrate) and depress plunger.Instill entire amount of sterile water 10 ml.9.Attach statlock® foley stabilization device to the bifurcation (y shape) of the foley catheter (statlock foley stabilization device can be used for up to 7 days) and apply.(refer to the instructions for use provided with the statlock foley stabilization device pouch for more details).10.If the procedure pack includes a leg bag, utilize the leg straps provided to secure the leg bag to the patient¿s leg, making sure not to affect circulation or drainage of urine.11.Ensure catheter and drainage bag tubing is kink free and drainage bag is positioned below the bladder to ensure urine is flowing freely.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.1.Kink the drainage tubing at a minimum of 5 cm below the sampling port.2.Wipe the surface of the port with an alcohol swab.3.Using an aseptic technique, position the syringe (luer slip tip only) in the center, perpendicular to the surface of the port, and then press the tip of the syringe into the sampling port.4.Aspirate the desired volume and then remove the syringe.5.Wipe the surface of the port with an alcohol swab.6.Unkink the tubing and send the correctly labelled specimen to the laboratory." 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 while removing the patient¿s foley catheter during handover, the user was told that the foley had not been draining during the night and observed 25ml in the urometer.Stated that the catheter tubing was straight to the statlock, no kinks, also the tubing was over the leg just below the knee, no lasso and downward angle to the side at the end of the bed.Customer stated that while walking the patient to the bathroom the customer heard the urine draining into the urometer.Also, the patient sat on the toilet and the customer removed the foley and emptied 325ml.Stated that the foley catheter had not been draining properly.
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