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It was reported that there was a resistance removing the foley catheter on two separate occasions.Stated that the nurse had to pull it out and this caused the patient discomfort.When reviewing the catheter after pulling from patient, they noticed an extra ridge on the tip of the catheter.No medical intervention was reported.Per additional information received via email on 13-dec-2022, stated that the urologist was consulted to remove one of the catheters, as the nurse did not feel comfortable removing the catheter once resistance was felt.
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It was reported that there was a resistance removing the foley catheter on two separate occasions.Stated that the nurse had to pull it out and this caused the patient discomfort.When reviewing the catheter after pulling from patient, they noticed an extra ridge on the tip of the catheter.No medical intervention was reported.Per additional information received via email on 13-dec-2022, stated that the urologist was consulted to remove one of the catheters, as the nurse did not feel comfortable removing the catheter once resistance was felt.
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The reported event is confirmed cause unknown.Visual received one photo sample focusing on end of catheter with balloon where balloon mushrooming was present.Therefore, product does not meet specifications which states "balloon must not cuff after deflation in accordance." although an exact root cause could not be determined a potential root cause could be balloon material does not shrink quickly enough.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: "bard® ez-lok® sampling port (indicated by the blue stem in the port) accepts luer lock (fig.1a) or slip tip syringes (fig.1b).1.Occlude drainage tubing a minimum of 3 inches below the sampling port by kinking the tubing until urine is visible under the access site.2.Swab surface of bard® ez-lok® sampling port with antiseptic wipe.(fig.2) 3.Using aseptic technique, position the syringe in the center of the sampling port.Press the syringe firmly and twist gently to access the sampling port.(fig.3) 4.Slowly aspirate urine sample into syringe and remove syringe from sample port.5.Unkink tubing if necessary and transfer urine specimen into specimen cup or follow hospital protocol.Discard syringe according to hospital protocol.6.Follow established hospital protocol for specimen labeling and transport to lab.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.Caution: federal (u.S.A.) law restricts this device to sale by or on the order of a physician.Single use only.Do not resterilize.For urological use only.Warning: on catheter, do not use ointments or lubricants having a petrolatum base.They will damage the catheter and may cause balloon to burst.Warning: after use, this product may be a potential biohazard.Handle and dispose of in accordance with accepted medical practices and applicable local, state and federal laws and regulations.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.Please consult product label and insert for any indications, contraindications, hazards, warnings, cautions and directions for use.Proper techniques for urinary catheter insertion ¿ perform hand hygiene immediately before and after insertion ¿ insert urinary catheters using aseptic technique and sterile equipment ¿ use the smallest foley catheter possible, consistent with good drainage ¿ document the indications for catheter insertion, date and time of catheter insertion, individual who inserted catheter, and date and time of catheter removal in patient record proper techniques for urinary catheter maintenance ¿ secure the foley catheter, use the statlock® foley stabilization device if provided ¿ maintain a closed drainage system by utilizing pre-connected, sealed catheter-tubing junctions ¿ maintain unobstructed urine flow and keep the catheter and collection tube free from kinking ¿ keep the collection bag below the level of the bladder or hips at all times ¿ empty the collection bag regularly (e.G., prior to transport) using a separate, clean collection container for each patient ¿ routine hygiene (e.G., cleansing of the meatal surface during daily bathing or showering) is appropriate ¿ leave foley catheter in place only as long as needed foley catheter removal 1.To deflate catheter balloon: gently insert a luer lock or slip tip syringe in the catheter valve.Never use more force than is required to make the syringe ¿stick¿ in the valve 2.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 3.Use only gentle aspiration to encourage deflation if needed.Vigorous aspiration may collapse the inflation lumen, preventing balloon deflation 4.If the balloon will not deflate and if permitted by hospital protocol, the valve arm may be severed.If this fails, contact adequately trained professional for assistance, as directed by hospital protocol 5.Should balloon rupture occur, care should be taken to assure that all balloon fragments have been removed from the patient directions for use 1.Wash hands and don clean gloves 2.Use the provided packet of wipes to cleanse patient¿s periurethral area 3.Explain procedure to patient and open peri-care kit 4.Remove gloves and perform hand hygiene with provided alcohol hand sanitizer gel 5.Place underpad beneath patient, plastic/¿shiny¿ side down note: use caution to maintain aseptic technique note: use of less than 10cc can result in asymmetrically inflated balloon 6.Don sterile gloves 7.Position fenestrated drape on patient 8.Remove foley catheter from wrap and lubricate catheter 9.Proceed with catheterization in usual manner using the dominant hand a.When catheter tip has entered bladder, urine will be visible in the drainage tube b.Insert catheter two more inches and inflate catheter balloon 10.Once inflated, gently pull catheter until the inflated balloon is snug against the bladder neck 11.Secure the foley catheter to the patient use the statlock® foley stabilization device if provided (see statlock® foley stabilization device ifu) note: please make sure patient is appropriate for use of statlock® stabilization device 12.Position hanger on bed rail at the foot of the bed note: exercise care to keep bag off the floor 13.Use green sheeting clip to secure drainage tube to the sheet.Make sure tube is not kinked 14.Indicate time and date of catheter insertion on provided labels.Place designated labels on patient chart and drainage system 15.Document procedure according to hospital protocol 16.Inflate catheter balloon using entire 10cc of sterile water provided in the prefilled syringe" correction: g.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 actual/suspected device was inspected.
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